Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery

ABSTRACT

The invention is methods and devices which a surgeon may use to stabilize the beating heart during a surgical procedure on the heart. Pursuant to the invention, a stabilizing device is introduced through an opening in the chest and brought into contact with the beating heart. By contacting the heart with the device and by exerting a stabilizing force on the device, the motion of the heart caused by the contraction of the heart muscles is effectively eliminated such that the heart is stabilized and the site of the surgery moves only minimally if at all. Typically, in separate steps, the surgeon contacts the heart with the stabilizing means, assesses the degree of movement of the anastomosis site, and exerts a force on the stabilizing means such that the contraction of the beating heart causes orgy minimal excess motion at the surgery site. By fixing the position of the stabilizing means in a configuration where the motion of the beating heart is effectively eliminated, the surgeon is able to stabilize the beating heart for the duration of the procedure. The stabilizing means may be attached to a rigid support or may be attached to a semi-rigid support which is rendered motionless mechanically, chemically, or by human intervention. In certain preferred embodiments, the stabilizing means is affixed to a semi-rigid support which is caused to become rigid, by any of a variety of techniques, such that the position of the stabilizing means becomes fixed by the -support, and the heart remains substantially motionless for the duration of the procedure.

[0001] This application is a continuation-in-part of co-pending U.S.Ser. No. 08/789,751 filed Jan. 27, 1997 which is a continuation-in-partof co-pending U.S. Ser. No. 08/603,758 filed Feb. 20, 1996.

[0002] Diseases of the cardiovascular system affect millions of peopleeach year and are a leading cause of death throughout the world. Thecosts to society from such diseases is enormous both in terms of thelives lost and in terms of the cost of treating patients throughtraditional surgical techniques. A particularly prevalent form ofcardiovascular disease is a reduction in the blood supply leading to theheart caused by atherosclerosis or other condition that creates arestriction in blood flow at a critical point in the cardiovascularsystem that supplies blood to the heart. In many cases, such a blockageor restriction in the blood flow leading to the heart is treated by asurgical procedure known as a Coronary Artery Bypass Graft (CABG)procedure, more commonly known as a “heart bypass” operation. In theCABG procedure, the surgeon “bypasses” the obstruction to restore normalblood flow to the heart by attaching an available source vessel to anobstructed target coronary artery or by removing a portion of a vein orartery from another part of the body, to use as a graft, and byinstalling the graft at points between a source vessel and a targetartery to restore normal blood flow.

[0003] Although the CABG procedure has become relatively common, theprocedure itself is lengthy and traumatic and can damage the heart, thecardiovascular system, the central nervous system, and the blood supplyitself. In a conventional CABG procedure, the surgeon must make a longincision down the center of the chest, cut through the entire length ofthe sternum, perform several other procedures necessary to attach thepatient to a heart-lung bypass machine, cut off the blood flow to theheart, and then stop the heart from beating in order to complete thebypass. The most lengthy and traumatic surgical procedures arenecessary, in part, to connect the patient to a cardiopulmonary bypass(CPB) machine to continue the circulation of oxygenated blood to therest of the body while the bypass is completed.

[0004] Although several efforts have been made to make the CABGprocedure less invasive and less traumatic, most techniques stillrequire cardiopulmonary bypass (CPB) and cardioplegia (stopping theheart). The safety and efficacy of the CABG procedure could be improvedif the surgeon could avoid the need to stop the heart from beatingduring the procedure, thereby eliminating cardiopulmonary bypass and thelengthy and traumatic surgical procedures necessary to connect thepatient to a cardiopulmonary bypass machine to sustain the patient'slife during the procedure. In recent years, a small number of surgeonshave begun performing CABG procedures using surgical techniquesespecially developed so that the CABG procedure could be performed whilethe heart is still beating. In such procedures, there is no need for anyform of cardiopulmonary bypass, no need to perform the extensivesurgical procedures necessary to connect the patient to acardiopulmonary bypass machine, and no need to stop the heart. As aresult, the surgery is much less invasive and the entire procedure cantypically be achieved through a small number, typically one or two,comparatively small incisions in the chest.

[0005] Despite the advantages, the beating-heart CABG procedure is notwidely practiced, in part, because of the difficulty in performing thenecessary surgical procedures using conventional surgical instruments.If specially designed instruments were available so that the CABGprocedure could be performed on the beating heart, the beating-heartCABG procedure would be more widely practiced and the treatment ofcardiovascular disease in a significant patient population would beimproved.

[0006] As noted above, the CABG procedure requires that a fluidconnection for restoring the flow of blood be established between twopoints to “bypass” a diseased or obstructed area to restore blood flowto the heart. This procedure is known as an “anastomosis. ” Typically, asource vessel, such as a source artery with an unobstructed blood flow,i.e., the left internal mammary artery (LIMA), or a bypass-graft havingone end sewn to an unobstructed blood source such as the aorta, is sewnto a target occluded coronary artery, such as the left anteriordescending (LAD) artery or other vessel, that provides blood flow to themuscles of the heart. Because the beating-heart CABG procedure isperformed while the heart muscle is continuing to contract and pumpblood, the anastomosis procedure is difficult to perform because theheart continues to move while the surgeon is sewing the anastomosis.

[0007] The specific part of the surgical procedure that creates theanastomosis in the beating-heart CABG procedure requires placing aseries of sutures through extremely small vessels on the surface of theheart and requires completing the anastomosis while the heart musclecontinues to beat to pump blood during the procedure. Moreover, thesutures must be carefully placed so that the source vessel or graft isfirmly attached when the anastomosis is complete and does not leak whenblood flow through the vessel is established. It is also important thatthe anastomosis procedure be performed rapidly because the blood flowthrough the target coronary artery may be temporarily interrupted orreduced to avoid excessive blood loss. Also, the working space andvisual access are limited because the surgeon may be working through asmall incision in the chest or may be viewing the procedure on a videomonitor if the site of the surgery is viewed via a surgical scope.

[0008] In one current practice, the surgeon places sutures through theheart tissue and, by exerting opposing tension on the sutures, stretchesthe tissue surrounding the site of the anastomosis to partially reducethe motion of the heart while the anastomosis is completed. Thisapproach is far from ideal. Alternatively, a suction device may beattached to the surface of the heart to fix the motion of the outerlayer of surface tissue. In such cases, a suction device typically hasseveral ports incorporated into an instrument that may be attached tothe heart to apply a negative pressure to the surface tissue. Thenegative pressure essentially attaches the surface tissue to theapparatus thereby fixing the position of a portion of the surface of theheart. Such devices are described in co-pending U.S. patent applicationNo. 603,328.

[0009] While the negative pressure approach may be effective in fixing aportion of the surface tissue of the heart, the negative pressureapplied to cardiac tissue can result in temporary hematomas at the sitewhere the suction ports attach to the tissue. Also, the exterior cardiactissue is fixed in a configuration defmed by the shape of the instrumentand the orientation of the suction ports. While the heart continues tobeat, the heart muscles are contracting to pump blood, which results inthe muscles exerting a force directed- away from the exterior tissuefixed by suction.

[0010] The beating-heart CABG procedure could be greatly improved if theheart could be stabilized during the procedure such that the motion ofthe heart, particularly at the site of the anastomosis, is minimizedeven though the heart continues to beat to supply blood to the body. Ifeffective means for stabilizing the beating heart were available, thebeating-heart CABG procedure could be performed more easily, morerapidly, more safely, and with less trauma to the patient.

SUMMARY OF INVENTION

[0011] The advantages provided to a surgeon by the instruments andtechniques of the invention allow the beating heart CABG procedure to beperformed more rapidly, with less trauma to the patient, and enable asurgeon to perform a CABG procedure without CPB or cardioplegia. Thisinvention provides an alternative approach to a suction apparatus byproviding devices and methods for stabilizing the motion of the heartusing mechanical instruments specially designed to apply a stabilizingforce to the heart to minimize the motion of the beating heart during asurgical procedure. The invention enables a surgeon to readily andrapidly perform a beating-heart CABG procedure thus avoiding the needfor cardioplegia or cardiopulmonary bypass. In particular, the methodsand devices described herein enable the surgeon to stabilize the heartsuch that an anastomosis can be more readily accomplished by enablingthe surgeon to attach a source vessel or bypass graft to a targetcoronary artery whose motion is minimized for the duration of thesurgical procedure.

[0012] Pursuant to the invention, a stabilizing device is introducedthrough a suitable opening in the chest that provides access to thebeating heart. By contacting the heart with the means for stabilizingthe beating heart of this invention, and by exerting a stabilizing forceon the heart, the motion of the heart caused by the contraction of theheart muscles is effectively eliminated such that movement of the targetartery at the site of the anastomosis is minimized. The remainder of theheart may be allowed to contract normally or may have additional devicesin place to support the heart or to restrain its motion. Additionally,several of the devices of the invention may be used to position thebeating heart to provide an improved surgical field, to maintain theheart in a preferred configuration for surgery, or to rotate the heartto present distinct features of the heart to the surgeon's visible andaccessible surgical field.

[0013] An important advantage of this invention is derived from thediscovery that a new and effective technique can be described herein andperformed in surgery using the devices of the invention to provide anadvantageous technique for stabilizing or positioning the beating heartduring a surgical procedure. The procedure for stabilizing the beatingheart generally requires exerting a stabilizing force on the beatingheart using devices constructed as described herein. Typically, inseparate steps, the surgeon contacts the heart with at least onecomponent of the means for stabilizing the beating heart of thisinvention, assesses the degree of movement of the heart, particularly atthe site of the surgery, and positions the component of the stabilizingmeans proximate to the site of the surgery such as a target coronaryartery of an anastomosis. With the functional portion of a stabilizingmeans in place, the surgeon applies a stabilizing force to the beatingheart such that the portion of the instrument in contact with thesurface of the heart displaces the surface of the heart a sufficientdistance that the contraction of the heart does not cause substantialmotion, either vertical or horizontal, at the surgery site. Thestabilizing force is applied directly or indirectly using at least onecomponent of the stabilizing means of the invention and is comprised ofexerting a mechanical force onto the beating heart, generally at aspecific location such as a target coronary artery and generallyexerting force that is at least partially applied in a directionperpendicular to the surface of the beating heart. Thus, an importantaspect of this invention is the discovery that the beating heart may beeffectively stabilized for the purpose of a surgical procedure by usinga specially designed instrument as described herein to exert amechanical stabilizing force on the exterior of the heart, particularlywhere the force is exerted proximate to the site of the surgery. Thestabilizing force may consist of a force that resists the motionsupplied by the beating heart, or additional forces applied to theheart, or the stabilizing force.

[0014] By fixing the position of the stabilizing means in aconfiguration where the motion of the beating heart is effectivelyeliminated, the surgeon maintains the stabilizing force on the beatingheart for the duration of the procedure. To fix the position of themeans for stabilizing the beating heart, the stabilizing means may beattached to a retractor used to separate the ribs or to another fixedsupport. The stabilizing means may also be attached to a comformable,flexible, or semi-rigid arm or shaft means which is renderedsubstantially rigid mechanically, chemically, or by human intervention.In certain preferred embodiments, the stabilizing means has anadjustable shaft means which may be oriented in several directions andhas a fixture adapted to be attached to a retractor. In a preferredtechnique of the invention, the surgeon first performs a thoracotomy andretracts the ribs using a retractor, which may then be locked in an openposition providing access to the beating heart. The surgeon thencontacts the surface of the heart with a component of the stabilizingmeans, which has been provided with an adjustable shaft, at a pointproximate to the target coronary artery, and exerts a stabilizing forceon the means for stabilizing the beating heart. By manipulating theadjustable shaft, the site of the surgery will become substantiallymotionless. This force may be advantageously applied, and the absoluteamount of force minimized with the additional feature of an adhesive orhigh-friction surface on the component of the stabilizing means thatcontacts the beating heart. At this point, the adjustable shaft means isfixed in position, for example by being stably attached to theretractor, thereby rendering the target coronary artery substantiallymotionless for the duration of the procedure.

DESCRIPTION OF THE FIGURES

[0015]FIG. 1 is a means for stabilizing the beating heart having a pairof substantially planar contact members which are oriented to engage theheart proximate to the site at which a bypass will be sewn. FIG. 1 alsoshows the contact members attached to a shaft means which may beadjustable in several directions and which may be attached to aretractor or other fixed support structure. FIG. 1A is a detail of theshaft means and the structure of the adjustable positioning mechanisms.FIG. 1B through 1G are various configurations of a contact member havinga friction means which is preferably affixed to the bottom surface ofthe contact member.

[0016]FIG. 2 is an example of a snap-on member affixed to the bottomsurface of a contact member for ease of manufacture and disposabilityadvantages.

[0017]FIG. 3 is an example of a stabilizing means of the inventionhaving an inflatable or fluid-filled cushioning member disposed betweenthe bottom surface of the contact member and the surface of the beatingheart.

[0018]FIGS. 4A through 4C are an embodiment of the invention havingweighted contact members that engage the beating heart, and which may bepart of a system to achieve stabilization of the heart by applying astabilizing force via a balanced mass having an adjustable weight andcounterweight configuration. FIG. 4A shows the weighted contact memberin cross section. FIG. 4B is the contact members having an openingdisposed therebetween for positioning of a vessel. FIG. 4C shows thecontact member coupled to a shaft that is affixed to a fulcrum having anadjustable weight and a counter-weight.

[0019]FIG. 5 is an embodiment of the invention having a counter-contactmember positioned opposite a pair of contact members and having a shaftpositioned at an intermediate point therebetween.

[0020]FIGS. 6A and 6B are embodiments of the invention having contactmembers which have a conformable shape, and where a flexible orsemi-rigid member may be passed through the body of the contact member.

[0021]FIG. 7A is an embodiment of the contact member wherein the contactmember has ports for releasable attachment of the distal end of a shaftmeans. FIG. 7B is an embodiment wherein a plurality of ports aredisposed about the periphery of a contact member for releasableattachment to the distal end of a shaft means. FIG. 7C is an embodimentof the invention wherein a separate shaft is provided having distalportions adapted to fit within ports on a contact member. FIGS. 7D and7E are an embodiment of the invention wherein the contact members areformed from the distal portion of a shaft means for minimally invasiveapplications. FIG. 7E shows an interconnecting member for joining thedistal portions of the shaft means.

[0022]FIG. 8 is an embodiment of the invention having a substantiallyannular contact member which is affixed to a shaft which is rotatableabout the annular contact member and which may be locked into positionat a given point about the periphery of the contact member.

[0023]FIGS. 9A through 9G are embodiments of the invention where apositive or negative pressure is provided proximate to the contactmembers. FIG. 9H is an embodiment of the invention where a light sourceis provided to illuminate the area that the beating heart contacted bythe contact members.

[0024]FIGS. 10A through 10C are embodiments of the invention where asurgical drape is operably associated with the contact members toprovide an isolated visual field.

[0025]FIG. 11 is the contact members of the invention having anassociated apparatus to facilitate completing the anastomosis.

[0026]FIG. 12 is an embodiment of the invention where the shaft meanshas associated therewith a separate vessel holder.

[0027]FIGS. 13A through 13E are a cannula assembly preferred forproviding minimally invasive access for the stabilizing means of theinvention. FIG. 13A has screws for attaching the cannula assembly to thechest wall. FIG. 13B has a threaded portion about the periphery of thecannula. FIGS. 13C through 13E are a locking mechanism designed toengage adjacent ribs.

[0028]FIG. 14 is a conical cannula having a smaller distal end to engagethe surface of the beating heart and a larger proximal opening forintroducing surgical instruments to the beating heart.

[0029]FIGS. 15A and 15B are an embodiment of the invention insertedthrough the chest wall in a minimally invasive fashion via a cannula tobring the contact members into engagement with the beating heart.

[0030]FIGS. 16A through 16E are an embodiment of the invention designfor minimally invasive insertion and removal of flexible contact memberswhereby the contact members are maintained in a retracted state within ahollow portion of a shaft and are deployed upon extension of a centralshaft.

[0031]FIGS. 17A through 17D are an additional embodiment providingminimally invasive insertion and removal of the contact members of theinvention whereby individual contact members are rotated into positionby a hinge at the distal end of a shaft.

[0032]FIGS. 18A through 18D are contact members which are attached to aguide that is positioned about a shaft such that downward movement ofthe guide causes the contact members to be deployed.

[0033]FIGS. 19A and 19B are contact members of the invention attached toa shaft means by a plurality of struts that extend the contact membersinto position.

[0034]FIGS. 20A through 20E are contact members of the invention thatare rotatable about the distal portion of a shaft means by a pluralityof hinges.

[0035]FIGS. 21A through 21C are an embodiment having contact membersformed from a unitary wire which is looped such that when extended froma body of the device, the contact members are deployed, and may beremoved in a minimally invasive fashion by withdrawing a portion of thewire into the body of the device.

[0036]FIGS. 22A through 22C are an embodiment of the invention whereinthe contact members are formed from a helical coil which may bewithdrawn into the hollow portion of a shaft for minimally invasiveinsertion and removal.

[0037]FIGS. 23A and 23B are inflatable contact members that may bedeflated for insertion or removal by being drawn into the body of ashaft.

[0038]FIGS. 24A and 24B are a contact member of the invention formedfrom an inflatable annular cuff.

[0039]FIGS. 25A and 25B are contact members formed from the dividedportion of the distal end of a shaft.

[0040]FIGS. 26A through 26C are contact members having suturesassociated therewith for manipulation of a target artery.

[0041]FIGS. 27A and 27B are an intravessel stabilizer adapted to fitwithin the target coronary artery.

[0042]FIGS. 28A and 28B are contact members of the invention havingmeans associated therewith for positioning said epicardial tissue.

[0043]FIGS. 29A and 29B are contact members of the invention havingrotatable cylindrical rollers for collecting or spreading epicardialtissue proximate to a target artery.

[0044]FIG. 30 is a means for stabilizing the beating heart having a pairof contact members which are additionally comprised of aspring-tensioned frame having an extension that engages and spreads thetissue at the site of the surgery to better expose the coronary artery.

[0045]FIGS. 31A and 31B are embodiments of the stabilizing means havinga single shaft means associated with each contact member and where theshaft means are interconnected and can be moved independently about apivot such that the contact members spread the surface tissue of theheart proximate to the target coronary artery to increase exposure ofthe target artery at the site of the anastomosis.

[0046]FIGS. 32A through 32C are embodiments of the invention wherein thecontact members have additional structures associated therewith forretraction of epicardial tissue, the epicardial retractors may becomprised of pins which extend from the bottom surface of the contactmember.

[0047]FIGS. 33A and 33B are means for stabilizing the beating heartcomprising a system which incorporates the retractor which spreads theribs to provide surgical access to the heart. The stabilizing means iscomprised of a pair of stabilizing plates which may be used togetherwith a lever device to improve exposure of the target coronary artery.

[0048]FIGS. 34A through 34D are an embodiment of the invention having alockable mechanism for depressing epicardial tissue on either side of atarget coronary artery.

[0049]FIG. 35 is a substantially planar stabilizing platform whichcontacts the heart at a site proximate to and surrounding the coronaryvessel. The platform may also have associated therewith at least oneoccluder which restricts or eliminates blood flow through an artery andan associated device for spreading the tissue proximate to theanastomosis.

[0050]FIG. 36 is an artery occluder comprised of a shaft portion andhaving a blunt portion to engage a target artery.

[0051]FIGS. 37A through 37C are contact members having structuresassociated therewith for occluding the target coronary artery.

[0052]FIGS. 38A and 38B are contact members of the invention having aflange associated therewith for use with sutures that surround thetarget vessel and may be used in connection with a movable shaft orsuture guide to occlude the target vessel.

[0053]FIG. 39 is an embodiment of the contact member of the inventionhaving one or more fixtures attached, preferably to a planar surfacethereof, and adapted to receive a surgical tool or accessory such asscissors, forceps, or surgical needles for the convenience of thesurgeon during the anastomosis procedure.

[0054]FIG. 40 is an embodiment of the invention having flex jointsbetween the contact members, the interconnecting shaft, or the shaftmeans to provide continuous positioning of the contact members.

[0055]FIG. 41 is an embodiment of the invention having lockable jointsassociated with the shaft means.

[0056]FIG. 42 is a flexible, lockable arm which allows positioning inevery direction to place and orient the contact members until therequisite degree of stabilization is achieved at which point the armhaving a stabilizing means is fixed in position. The flexible, lockablearm may be attached to a retractor and is caused to become rigid whenthe entire stabilizing means is properly positioned.

[0057]FIG. 43 is a conformable, lockable arm having hollow cylinders andspheres and an inflatable balloon member disposed therein to lock thearm into position.

[0058]FIGS. 44A and 44B are embodiments of the invention having curvedinterlocking segments wherein teeth formed at the interconnectingsurfaces of each segment prevent rotation of the respective segments.

[0059]FIGS. 45A and 45B are a flexible shaft having means incorporatedtherein for fixing the position of the shaft.

[0060]FIGS. 46A through 46C are an embodiment of the invention where aseries of adjustable links have a elastomeric hydraulic median disposedtherein and where application of force causes the elastomeric hydraulicmedian to become rigid and fixes the position of the adjustable links.

[0061]FIG. 47 is an embodiment of the invention having a flexible shaftwith a plurality of strands located therein wherein locking the strandsin position at a distal portion causes the shaft to become rigid.

[0062]FIG. 48 is a flexible shaft having a plurality of lumens disposedtherein such that sealing of the lumens fixes the position of theflexible shaft.

[0063]FIG. 49 is a fine adjusting mechanism wherein a plurality ofthreaded cables are attached to a proximal portion of a shaft meanswhereby turning the threaded cables causes the proximal portion of theshaft means to be adjusted.

[0064]FIGS. 50A and 50B are embodiments of the shaft means havingspring-loaded or air-damping mechanisms to restrict the vertical motionof the shaft relative to a stable support.

[0065]FIG. 51A and 55B are shaft means of the invention provided withfine adjustment mechanisms for vertical positioning of the shaft.

[0066]FIG. 52 is a malleable shaft that is mounted on a fixture attachedto a retractor blade and having a handle for vertical positioning of theshaft.

[0067]FIG. 53 is a shaft means comprised of an adjustable arm formedfrom several interlocking segments attached to a cable.

[0068]FIGS. 54A through 54C are an adjustable shaft means of theinvention wherein the position of the contact members are adjusted by apositioning handle located at the proximal portion of the shaft meansand connected to a ball joint at the distal portion by a plurality ofpositioning wires.

[0069]FIG. 55A is an embodiment of the stabilizing means of theinvention having stabilizer bars suspended from the bottom side of a ribretractor wherein the stabilizer bars engage a ratchet means. FIG. 55Bhas malleable shafts attached to a retractor and to the contact members.

[0070]FIGS. 56A through 56D are a shaft means of the invention havingmechanisms for adjustable positioning of the shaft relative to a stablesupport.

[0071]FIG. 57 is an adjustable arm for attaching a shaft means of theinvention to a stable support wherein the shaft means passes through aball joint that is adjustable by a fixture on the arm and wherein thearm is locked in place on the stable support by a latch mechanism.

[0072]FIGS. 58A through 58C are embodiments of the shaft means of theinvention for adjustable positioning of the shaft means relative to aretractor blade.

[0073]FIGS. 59A through 59C are adjustable shaft means of the inventionthat extend from a retractor blade or a retractor arm and arecontinuously positioned relative to the retractor blade or retractorarm.

[0074]FIG. 60 is an embodiment having a central shaft with a handle atthe proximal end that is positioned by a plurality of shaft guides whichare preferably attached to a interconnecting arm affixed to a retractor.

[0075]FIG. 61 is an embodiment of the stabilizing means of the inventionhaving a pair of plates operably associated with a rib retractor and asphere disposed between the plates to facilitate orientation of theshaft means.

[0076]FIG. 62 is an embodiment of the invention having a shaft meanscomprised of an arm which extends from the interconnecting bar of aretractor to a position below the retractor blades and has asubstantially horizontal shaft.

[0077]FIG. 63 is the means for stabilizing the beating heart of theinvention operably associated with a rib locking mechanism.

[0078]FIG. 64 is the stabilizing means of the invention adapted to beused as a means for positioning the beating heart, wherein the means areoperably associated with a rib locking mechanism.

[0079]FIGS. 65A through 65D are embodiments of the invention where theshaft means is comprised of a unitary hollow shaft.

[0080]FIG. 66 is a means for stabilizing the beating heart having asheath member with several pliable support attachments associatedtherewith which may include or be comprised of inflatable members whichare positioned at one or several locations surrounding the heart and mayhave a lumen disposed within the sheath member for the introduction ofair or a biocompatible fluid.

[0081]FIG. 67 is a stabilizing means formed from a movable sheath memberthat is attached at either end to cranks mounted on the arms of aretractor.

[0082]FIGS. 68A through 68C are a device for advantageous positioning ofthe heart comprised of a flexible sheet, preferably having a hydrogelcoating on one side.

[0083]FIG. 69 is an embodiment of the invention comprised of a pluralityof telescoping shafts having the contact member affixed at their distalend and wherein the position of the telescoping shaft is manipulated andfixed by a hydraulic actuators.

[0084]FIG. 70A through 70D are an embodiment of the invention having aconformable arm comprised of a plurality of friction joints that areengaged when the motion of the beating heart presses against the contactmember.

[0085]FIGS. 71A through 71D are an embodiment of the invention having acontractible shaft attached to a flexible slide. The flexible slide isdesigned to be inserted into a seed-shaped clip which may be attached toa retractor blade. The contractible shaft is extended to engage thebeating heart by application of hydraulic pressure, for example, by asyringe that is preferably supplied with a one-way releasable valve.

[0086]FIG. 72 is a view of the interior of the chest cavity during aCABG procedure on the beating heart with the stabilizing means operablyassociated with a retractor and being used in conjunction with othersurgical apparatus to facilitate completing the anastomosis.

[0087]FIGS. 73 and 74 show the stabilizing means of the invention havingbeen introduced through a thoracotomy to contact the beating heart toengage the heart tissue on either side of a target coronary artery towhich an anastomosis is sewn.

[0088]FIG. 75 is an embodiment of the invention having a pair of shaftmeans operably associated with ball joints that are affixed to opposingarms of a retractor.

[0089]FIG. 76 is a further embodiment of the invention including meansfor stabilizing the beating heart and a quick-locking base/shaft lockmechanism for solid attachment of the stabilizing means to a stableplatform.

[0090]FIG. 77 is an exploded perspective view of the stabilizing meansof FIG. 76, including a shaft-locking support mechanism for maneuverablysupporting a shaft means of the stabilizing means.

[0091]FIGS. 78 and 79 are perspective views of the top and bottom,respectively, of a base of FIGS. 76, 77.

[0092]FIG. 78A is a perspective view of one side of a pedestal meansformed on a retractor arm.

[0093]FIG. 80 is a side view of the base of FIGS. 76-79 locked to aretractor arm.

[0094]FIG. 81 is a cross-sectional view of the base and retractor armtaken along section line 81-81 of FIG. 80.

[0095]FIGS. 82 and 83 are side and top cross-sectional viewsrespectively, of the shaft-locking support mechanism of FIG. 77.

[0096]FIGS. 82A and 82B are a cross-sectional view taken along sectionline 82A-82A of

[0097]FIG. 82, and a bottom view of the shaft-locking support mechanism,respectively.

[0098]FIGS. 84 and 85 are side and top cross-sectional views of theshaft-locking mechanism employing an alternative shaft lockconfiguration.

[0099]FIG. 86 is a perspective view of the alternative shaft lock ofFIGS. 84, 85.

[0100]FIGS. 87 and 88 are exploded perspective and cross-sectional viewsrespectively of a handle mechanism of the stabilizing means.

[0101]FIG. 89 is an exploded perspective view of a contact member of thestabilizing means.

[0102]FIG. 90 is a rear view of the contact member of FIGS. 76, 77 and89.

[0103]FIG. 91 is a cross-sectional view of the contact member of FIG. 90taken along section line 91-91.

DETAILED DESCRIPTION OF THE INVENTION

[0104] This invention is surgical instruments for stabilizing thebeating heart and methods for their use. The means for stabilizing thebeating heart are comprised of several alternative structures at leastone component of which engages the surface of the heart to stabilize thebeating heart during coronary surgery. The instruments provide thecapability to exert and maintain a stabilizing force on the heart bycontacting the heart with a component of the stabilizing means and byfunctionally fixing the position of the stabilizing means throughout theduration of a surgical procedure.

[0105] The instruments and methods of the invention are preferably usedfor stabilization of the beating heart during a minimally invasivecoronary artery bypass graft (CABG) operation which has been speciallydeveloped to facilitate completion of an anastomosis, to a targetcoronary artery for example by the placement of a bypass graft or theconnection of a source artery, without requiring cardiac arrest such ascardioplegia or fibrillation and without cardiopulmonary bypass (CPB).Although the means for stabilizing the beating heart can be applied indifferent surgical contexts, the devices described herein are mostadvantageously employed in a CABG procedure wherein only one or twominimally invasive incisions are placed in the chest. The completestructure of the stabilizing means of the inventor may be provided byany of several structural embodiments which stabilize the beating heartwhile the minimally invasive surgical procedure is performed. Discretecomponents of the stabilizing means may also advantageously function ina multiple component system containing a retractor, an occluder, asurgical blower or suction device, an apparatus for holding the sourceartery, such as -a LIMA holder, or other like discrete or integratedsurgical devices or instruments that enable a surgeon to moreefficiently complete the anastomosis. While the devices disclosed hereineach use mechanical means to stabilize the beating heart, certainembodiments are designed to operate on the entire heart while othershave a more localized effect and may be applied to the area immediatelyproximate to a structure such as the target artery of the anastomosis.In each instance, the beating heart is effectively stabilized at thearea where a surgical procedure is to be performed.

[0106] Surgical access to the beating heart may be achieved by severalconventional surgical procedures which have been developed fortraditional cardiac bypass surgery and the surgeon may thereby obtainthe advantages provided by this invention in any procedure where thebypass is achieved on the beating heart without regard to the surgicalmethod of access to the heart. Preferably, the surgeon takes additionalmeasures to restrict the movement of the entire heart within the chestcavity and may utilize certain embodiments disclosed herein to positionor orient the beating heart. For example, an adjustable strap which mayhave inflatable cushions attached to the straps, or having laces may beinserted beneath or surrounding the heart. When access to the beatingheart is achieved by a sternotomy, at least part of the length of thesternum is divided to expose the surface of the heart. Additionally,when the pericardium is available, the pericardium may be incised andused to position the beating heart. When available, the surgeon can usethe pericardium to raise and rotate the beating heart within the chestcavity and maintain the position by suturing the pericardium to theperiphery of the incision.

[0107] In a preferred embodiment, minimally invasive access to thebeating heart is achieved by a thoracotomy, which is usually created inthe left side of the chest by a smaller incision between the ribs,followed by insertion of a retractor between the ribs, spreading of theribs, and securing the retractor in an open position to provide accessto the source vessel and the target coronary artery. The use of thepericardium to position the beating heart as described above isparticularly advantageous when the less invasive thoracotomy is used toprovide access to the heart. In this procedure, an incision is createdin the pericardium, which is then sutured to the periphery of thethoracotomy. In this configuration, the pericardium acts as arestraining sack to keep the beating heart in a desired orientation toachieve the anastomosis.

[0108] Once access to the heart is achieved, and the heart is positionedif necessary, the means for stabilizing the beating heart is introducedthrough the opening created by the thoracotomy and at least onecomponent of the stabilizing device of the invention is brought intocontact with the beating heart. The surgeon then applies a stabilizingforce to the beating heart via the stabilizing means which may then befixed in place by attachment to a fixed support. When the rib retractoror platform is fixed in an open position to expose the heart, theretractor platform may also provide the stable support structure towhich the stabilizing means is affixed. When the position of thestabilizing means is fixed by attachment to a stable support or to theretractor platform, the stabilizing force is maintained for the durationof the procedure.

[0109] Although the particular source vessel and target artery of theanastomosis are determined clinically, a common minimally invasivebypass procedure on the beating heart includes an anastomosis whichforms a connection between the left internal mammary artery (LIMA) asthe source artery, and the left anterior descending artery (LAD) as thetarget artery. The LIMA to s LAD anastomosis is used as an exampleherein but it is readily appreciated that the techniques and instrumentsdescribed herein may be applied to other procedures depending on theclinical diagnosis and a patient's anatomy. To complete the anastomosis,the surgeon must dissect a portion of the LIMA by separating it from theinternal chest cavity. Once dissection of the LIMA is achieved, thesurgeon may attach the dissected LIMA to the target coronary artery,i.e., the LAD. In this example, the stabilizing means of this inventionwould be used to stabilize the beating heart during at least the portionof the procedure during which the surgeon completes the anastomosis ofthe LIMA to the LAD.

[0110] The structure of the portion of the stabilizing means whichcontacts the heart may include one or more contact members which exert astabilizing force on the heart proximate to the site of the anastomosis.A pair of contact members may be plates or rectangular members which areplaced on either side of the target coronary artery at the site of theanastomosis and which may have friction means or tissue spreading orcompressing apparatus associated therewith. The contact members may alsobe provided by a platform which may be substantially planar or which maybe contoured to fit conformingly on the surface of the heart. Thestabilizing means may also include a shaft means having severalalternative embodiments to facilitate adjusting the position andorientation of the instrument. For example, the shaft means may have anadjustable length and the axis of the shaft means may have at least oneball joint disposed within its length such that the orientation of theshaft means relative to another structure such as the contact members orstable, support may be continuously varied. As is apparent from thedescription of the several embodiments, each of the individualembodiments described and illustrated herein has, discrete componentsand features which may be readily separated from or combined with thefeatures of any of the other several embodiments without departing fromthe scope or spirit of the invention.

[0111] Referring to FIG. 1, a means for stabilizing the beating heart iscomprised of one or more, and preferably two, contact members 1, whichare attached to a rigid, or semi-rigid connecting shaft 2 which is inturn connected to shaft means 3. The contact members 1 may besubstantially planar, may be slightly curved to conform to the shape ofthe heart, or may be a nor-conforming curve to establish contact betweenonly a portion of the contract member 1 and the beating heart. Thecontact members 1 may have any of several alternate shapes includingcylindrical members, members formed into a U-shape, or may comprise apair of substantially parallel members spaced apart in a parallelconfiguration such that a target artery can be positioned between thecontact members. The shape of the contact members may be varieddepending on the clinical assessment by the surgeon, the design of theother features of the stabilizing means, or the design of otherinstruments used to complete the anastomosis. In some embodiments, asdescribed herein, the contact members 1 may have apertures, openings orattachments to facilitate connection with sutures or other devices toachieve the requisite stabilization, occlusion of the target vessel, orexposure of the target vessel. In a preferred embodiment, a pair ofsubstantially planar rectangular contact members 1 are attached at oneend to a continuous connecting shaft 2 and are oriented in asubstantially parallel fashion such that a target cardiac artery ispositioned therebetween and passes along the greater length of thecontact members 1 when the stabilizing means engages the heart. SeeFIGS. 72 through 74. The connecting shaft 2 may be a continuous shaftfor interconnection of the contact members 1 without touching the arteryor may include an additional member which may be operated to contact thetarget artery positioned between the contact members 1, see FIGS. 36through 38, to occlude the passage of blood through the target artery.The contact members 1, connecting shaft 2, and shaft means 3 may becomposed of any non-toxic material such as a biocompatible plastic orstainless steel, having sufficient tensile strength to withstand astabilizing force exerted on the heart via manipulation or fixation ofthe shaft means 3 to cause the contact members 1 to exert a stabilizingforce on the beating heart. Also, while the contact members 1 may eachbe connected to the connecting shaft 2 at one end, with the connectingshaft 2 operably attached to the shaft means 3, each of the individualcontact member embodiments described and illustrated herein has discretefeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments, such as differingdesigns of the shaft means, or other components of the invention by oneof ordinary skill in the art.

[0112] The shaft means 3 may be a simple rigid post or may be comprisedof a multi-component system designed to be adjustable in length andorientation at least one point along its length.

[0113] Thus, the length of the shaft means 3 and the orientation of thecontact members 1 at the distal (lower) end of the shaft means 3 can bealtered by the surgeon. Preferably, the length and orientation at theshaft means 3 relative to the contact members 1 can be adjusted bycontrols located at the proximal (upper) end of shaft means 3. (As usedherein, the term “distal” refers to a portion of a device most proximalto the heart while the term proximal refers to the opposite portionwhich may extend outside of the incision and which is most often readilymanipulated by the surgeon). This design provides the advantage that thesurgeon can introduce the stabilizing means to the beating heart byplacing the contact members 1 on the surface of the heart, followed bythe combination of exerting a stabilizing force and locking the contactmembers 1 in place relative to the shaft means 3. Furthermore, thesurgeon may then lock the shaft means 3 into a fixed position byattachment to a stable support such as the retractor, therebymaintaining the stabilizing force for the duration of the procedure. Inone embodiment, the shaft means 3 has a housing 11 whose overall lengthis adjustable by a telescoping release operated by an annular thumbscrew8 which tightens about the housing 11. The position and orientation ofthe contact members 1 relative to the shaft means 3 is adjustable byvirtue of a locking ball joint 5 which is interposed between theconnecting shaft 2 and which is located at the distal end of shaft means3. The locking ball joint 5 allows the position of the shaft means 3 tobe positioned with three degrees of freedom relative to the contactmembers 1.

[0114] Referring again to FIG. 1, a locking ball joint 5 is provided byincluding a block 6 within the shaft means 3 which conformingly contactsthe ball joint 5 and fixes the position of the ball joint 5. Block 6 iscompressed against ball joint 5 when a threaded push block 7, connectedto a long telescoping keyed shaft and socket combination 9, and isactuated by means such as a thumbscrew 8 at the upper end of the shaftmeans 3. In operation, a rotation of the top thumbscrew 8 loosens thelower ball joint 5 to allow continuous positioning of the shaft means 3relative to the contact members 1, and a counter-rotation locks the balljoint 5 into place, fixing the position of the contact members 1relative to shaft means 3.

[0115] The upper end of shaft means 3 may also have associated therewithan upper ball joint 13 such that the shaft means 3 can be oriented withfour degrees of freedom relative to a fixed support such as a retractor(not shown). The position and orientation of the shaft means 3 may thusbe fixed relative to the stable support by a locking latch 14 or otherconventional mechanism which prevents movement of the upper ball joint13. Either the shaft means 3 or the retractor may contain the lockinglatch 14 surrounding the upper ball joint 13 or any like fixture tofirmly attach the shaft means 3 to a stable support, e.g., an anchorportion 15 extending from the retractor (not shown).

[0116] Referring to FIGS. 1B through 1G, the contact members 1preferably have friction means associated with their bottom surface 4such that the contact members 1 more securely engage the beating heartwhen a stabilizing force is exerted on the shaft means 3. The frictionmeans are preferably comprised of a textured surface covering the bottomsurface 4 of the contact member 1, and may be comprised of severalbio-compatible substances such as a textured rubber, textured or ridgedaluminum, stainless steel or the like.

[0117] The friction means may also be affixed to or comprised of amember disposed between the bottom surface 4 of the contact members 1and the surface of the beating heart. In these embodiments, the frictionmeans is provided to facilitate stabilization of the beating heart bymaintaining close and conforming contact between the contact member 1and the beating heart and reducing the amount of force necessary to beapplied to the exterior of the beating heart in order to achievestabilization. Referring to FIGS. 1B and 1D through 1G, any number ofdifferent configurations and may have a textured surface in a diamondplate, granular, nail-bed, anti-skid, open foam, or otherfriction-providing configuration. The geometric configuration of thesurface, having one side affixed to the contact member 1, may be flat,triangular, rectangular, square, or circular. Alternatively, surfacesproviding a functional adhesive may be obtained using hydrogel,fibrogen, collagen, hydroxy epitate, or other biocompatible material andmay be chemically etched, mechanically scored, or electricallyactivated.

[0118] Referring to FIG. 2, one practical method for providing thefriction means is a separate member affixed to the bottom surface 4 of acontact member 1 comprising a snap-in member 16 having means 17 forremovably attaching the snap-in member 16 to the bottom surface 4 of thecontact member 1. This removable attachment feature may be readilyprovided by a post 18 affixed to each snap-in member 16 and which fitsengagingly in a port 19 formed in the body of the contact member 1, orby other like configuration. This embodiment offers several advantagesin disposability and ease of manufacture, particularly where it isdesirable to provide an adhesive or friction-providing member separatelyto the bottom surface 4 of the contact member 1, and especially wherethe friction or adhesive member is formed of a different material thanthe body of the contact member 1. The bottom surface 4 of the snap-inmember 16 may have any of the configurations described previously (SeeFIGS. 1B and 1D through 1G).

[0119] Given the delicacy of the epicardial cardiac tissue, and thedesire to avoid the possibility for damaging the heart as it beatsthroughout the beating heart bypass procedure, and to avoid thepossibility that the stabilizing means might slip, the contact members 1of the invention may be provided with a friction-providing and/orcushioning material at the lower or bottom surface 4 of the contactmember 1 to cushion the point where the contact member(s) 1 engage thebeating heart. For example, FIG. 3 shows an exemplary material 20comprising a textured soft rubber or fluid-filled member affixed to thebottom or lower surface 4 of the contact members 1 to prevent damage tothe heart tissue, and to minimize slippage.

[0120] As noted above, a fundamental element of the invention is thecontact members which engage the surface of the beating heart, in someembodiments proximal to the site of the anastomosis, to directly applythe stabilizing force to the beating heart. The actual shape, size,configuration, and relative orientation of the contact members may varywithout departing from the spirit of the invention. For example,referring to FIGS. 4A and 4B, the contact members 1 that engage thesurface of the beating heart may be provided by a solid structure 21,preferably a dense metal, which provides an added weight to add to thestabilizing effect achieved by contacting the beating heart with thestabilizing means of the invention. This embodiment facilitates motioncancellation and stabilization of the beating heart by adding additionalweight directly at the site where the contact member engages the beatingheart, which in this embodiment is at the site of the anastomosis. Ascan be seen in FIG. 4B through line A-A of FIG. 4A, in this embodiment,two contact members 1 a, 1 b engage the beating heart at their lower orbottom surface 4, have a greater thickness at their outer edges, andhave an opening 22 positioned therebetween, and which traverses theentire space between the contact members 1 a, 1 b such that a vessel maybe positioned therebetween.

[0121]FIG. 4C shows an integrated apparatus which may advantageouslyapply the contact members 1 to the surface of the beating heart by theaction of a balance provided by an adjustable weight 24 andcounterweight 25 mounted on opposite ends of a shaft 26 mounted on afulcrum 27 which is preferably affixed to a stable support such as theoperating table or an access platform providing retraction during thesurgery. By manipulating the adjustable weight 24, varying degrees ofstabilizing force may be applied to the beating heart via shaft means 3and the contact members 1. This embodiment provides a continuouslyvariable quantity of stabilizing force directed downward by thepositioning of the weights 24, 25 and the rotation of the shaft 26 aboutthe point of the fulcrum 27. Thus, in use, the surgeon may rest thecontact members 1 on the surface of the beating heart with a minimalforce applied, and by moving the adjustable weight 24 away from thefulcrum, cause additional force to be applied, via the shaft means 3,and the contact members 1, to the surface of the beating heart.

[0122] The positioning of the contact members 1 at the surface of thebeating heart to provide the requisite degree of stabilization may beachieved by several techniques designed to apply a mechanical force tothe contact members that rest in a conformingly fashion at the surfaceof the beating heart to substantially arrest the movement in anatraumatic manner. The device shown in FIG. 5 has a pair of contactmembers 1 a, 1 b disposed in substantially parallel fashion as in theembodiments previously described. However, the device has an additionalcounter contact member 28 that also engages the surface of the beatingheart, but does so at a point slightly removed from the point ofengagement of the other contact members 1 a, 1 b which are preferablylocated at the site of the anastomosis. Additionally, the shaft means 3may be attached to and be rotatable about a point 29 located between thecontact members 1 a, 1 b and the counter contact member 28 andpreferably at a point on the connecting shaft 2 that is slightlyelevated. The shaft means 3 is preferably rotatable, for example byvirtue of a ball joint 30, about the point 29 of contact therebypermitting the contact members 1 to self-align and engagingly conform tothe surface of the beating heart. Moreover, in this embodiment, when astabilizing force is applied to the surface of the beating heart, theforce directed down the length of the shaft means 3 is not centered overthe site of the anastomosis. The counter contact member 28 may also beconfigured to occlude the target vessel 31. As with the otherembodiments disclosed herein, an embodiment of the type of FIG. 5 may beselected by the surgeon depending on the particular clinical indication,the particular physiology of a given patient, and/or the surgicalenvironment dictated by the access method used to gain access to thebeating heart, for example, sternotomy, thoracotomy, or punctureincision.

[0123] Thus, different surgical methods of access, different targetvessels, and the anatomical differences between individual patients, maydictate the use of alternate embodiments of the invention, typically atthe discretion of the surgeon. For this reason, contact members whichare continuously adjustable, may be particularly preferred for someclinical indications. For example, FIGS. 6A and 6B show an embodiment ofthe invention having a plurality of particles or beads 32 disposedwithin a substantially flexible tubular structure or structures 33, andwhich may have a vacuum lumen (not shown) located therein, to provide acontact means 1 whose shape and position is adjustable. Preferably, theflexible tube structure 33 has a malleable member 34 such as a wiredisposed along the length thereof to provide a structural memoryfunction and additional tensile strength. In the embodiment of FIG. 6A,the flexible tube 33 is a single unitary structure which can be bent,typically in a U-shape configuration, to engage the surface of the heartand may have plurality of discs 35 disposed along the malleable member34. Also, as illustrated by FIG. 6B, the stabilizing means may beprovided by a plurality of contact members 1 a, 1 b as otherwisedescribed herein. As with the single unitary structure of FIG. 6A, theplurality of the flexible contact members 1 a, 1 b may be provided witha plurality of beads or particles 32 disposed therein and mayadditionally have the ability to be inflated selectively, or selectivelydeflated, to adjust or fix the position of the contact members 1. Whensuction is applied via the suction lumen, the particles 32 arecompressed by atmospheric pressure causing the tubular structure 33 tobecome rigid, thereby fixing the information of the contact members 1.

[0124] As with the embodiments described above, adjustable placement ofthe contact members may be particularly useful in a minimally invasiveprocedure. Contact members that releasably contact or are releasablyattached to a shaft may be deployed- by separate insertion of thecontact member, and a shaft or shafts which may be independentlyintroduced, manipulated, and withdrawn to provide a stabilizing deviceheld in place by pressure exerted on the shafts while the anastomosisprocedure is performed at which time the contact members and shafts areremoved in an atraumatic manner. Referring to FIGS. 7A and 7B, a unitarycontact member 1 has a plurality of recessed ports 36 adapted to receivethe distal end 37 of a shaft means 3, wherein the distal end 37 isshaped to fit conformingly within the recessed port 36 and wherein theshaft means 3 may be removably attached to the contact member 1. As seenin FIG. 7B, this embodiment provides the advantage that the shaft means3 may be introduced through a plurality of very small incisions suchthat several shaft means 3 may removably engage the contact member 1 atthe several points about the periphery of the contact member 1 where therecessed ports 36 are formed in the contact member 1 and receive thedistal end 37 of a plurality a of shaft means 3.

[0125]FIG. 7C illustrates a separate removable shaft means 3a that maybe utilized with any of the embodiments of the contact members 1previously described. In FIG. 7C, the separate shaft means 3 a isseparately introduced and has a pair of distal ends 37 that engageequivalently oriented and spaced ports 36 found in the contact member 1to provide an additional positioning and stabilizing capability bymanipulating the separate shaft means 3 a when the distal ends 37 engagethe ports 36.

[0126]FIG. 7D is a simplified use of separate shaft means 3 a having anintegral contact member 1 formed from the distal portion 38 of theseparate shaft means 3 a. In this embodiment, the separate shaft means 3a are separately introduced into the surgical field through minimallyinvasive puncture incisions and are separately positioned to bring thedistal portion 38 of each of the separate shaft 3 a to contact thesurface of the heart. Referring to FIG. 7E, the separate shafts 3 a maybe joined at the most distal tip by a discrete interconnecting member 39having openings 40 configured to receive the most distal tip 37 of bothof the separate shaft means 3 a.

[0127]FIG. 8 is an additional embodiment of the contact members 1 of theinvention generally comprised of an annular structure 41 which isrotatable relative to the shaft means 3 which is attached at a pointabout the periphery of the contact member 1. In this embodiment, aportion of the bottom surface 4 of the annular portion 41 contacts thebeating heart at a site proximate to the target site for theanastomosis. The annular portion 41 of the contact member 1 may beprovided with a lockable fixture 42 which engages the distal end of theshaft 43, where the shaft means 3 contacts the annular structure 41, tolock the shaft in place. Alternatively, the shaft means 3 may rotatefreely about the periphery of the annular portion 41 of the contactmember 1. Preferably, a portion of the annular contact member 41 has apassage 44 formed through the bottom surface 4 of the annular contactmember 41 where the target vessel 45 passes beneath the annular contactmember 41. Additionally, the annular contact member 41 may havesubstantially planar surfaces 46 which are generally co-planar with thebottom surface 4 of the annular contact member 41 and have a rectangularopening therein for access to the target vessel 45. Planar surfaces 46may assist in providing stabilization at the tissue proximate to theanastomosis, and which also assist in positioning the target vessel 45relative to the annular contact member 41.

[0128] The contact members of the invention may also be provided withother related apparatus or fixtures that are commonly used intraditional surgical procedures. Such structures or fixtures may beoperably associated with the body of the shaft means 3, theinterconnecting shaft 2, or the contact members 1.

[0129] Referring to FIGS. 9A through 9E, a suction (negative) pressureor a blower (positive) pressure is useful to maintain a clear and dryanastomosis site. The positive or negative pressure may be provided tothe contact member by a plurality of ports 47 formed in the body of thecontact member. Each port is in pneumatic communication with a lumen 48that is in turn connected to a suction or positive pressure source.Thus, by exerting either a positive or negative pressure on lumen 48,the suction or positive pressure is applied to the site of theanastomosis via ports 47. In FIG. 9A, the ports 47 are disposed in thetop surface of the contact members 1 and have aligned openings in thedirection of the anastomosis site.

[0130] As shown in FIG. 9B, the plurality of ports 47 may be provided ina discreet lumen 48 which is affixed to, and runs longitudinally along,the length of the contact member 1. In this configuration, the pluralityof ports 47 are preferably disposed in a linear configuration along onesurface of lumen 48 to provide negative suction pressure or a positiveflow of pressure about the surface of the contact member 1.

[0131] Referring to FIG. 9C, as mentioned above, the plurality of ports47 and the lumen 48 may be provided in a manifold-like fashion whereinthe openings of the plurality of ports 47 are formed in the body of thecontact member 1, as is the lumen 48 which is in communication with eachport 47. As an alternate to the plurality of ports 47, a single slot maybe formed from the lumen 48, such that the slot runs along the greaterlength of the contact member 1 as shown in FIG. 9D.

[0132] Referring to FIG. 9E, in a variation on the embodiment of FIG.9B, the lumen 48 may be provided as a malleable tube which is separablefrom the contact member 1 along at least a malleable portion 49 of saidlumen 48. In this configuration, by manipulating the malleable tubeportion 49 of lumen 48, port(s) 47 may be selectively positioned at anypoint proximate to the contact member 1.

[0133] Referring to FIG. 9F, a manifold similar to that shown in FIG.9C, may be provided within the body of the contact member 1 in aconfiguration wherein the ports 47 are more closely associated with theinterconnecting shaft 2 or the shaft means 3. As in the embodiment ofFIG. 9C, the ports 47 are in communication with a lumen 48 that runs thelength of the shaft means 3 terminating in the plurality of ports 47. Asshown in FIG. 9F, the plurality of ports 47 may apply the positive ornegative pressure from the portion of the interconnecting shaft 2 thatjoins the individual contact members 1.

[0134] Referring now to FIG. 9G, as in FIG. 9E, a lumen 48 having amalleable portion 49 may be provided for selective positioning of apositive or negative pressure which may be applied at any pointproximate to the stabilizing means of the invention by manipulating theposition of the malleable portion 49 of the lumen 48 to selectivelyposition port 47.

[0135] In a similar structural configuration to FIGS. 9A through 9G,FIG. 9H supplies an incandescent or fiber optic light source 48aproximate to the contact members 1 by placing the light source withinthe shaft means 3 to have an opening or lens to provide light at thesite of the stabilization.

[0136] An additional conventional surgical apparatus which may beadvantageously applied to the stabilizing means of the present inventionis a selectively positionable surgical drape that assists in providing adry and sterile field, and which assists the surgeon during theprocedure by visually isolating the site of the anastomosis. FIG. 10Ashows a retractable and extendable drape 50 surrounding shaft means 3.In the retracted configuration 51, shown in phantom in FIG. 10A, theretractable drape is closely conformed to the shaft means 3 to beunobtrusive. The drape 50 may be affixed to the shaft means 3 by awasher element 52 that is directed downward to deploy the drape 50. Whenthe washer element 52 reaches the maximum downward position, theretractable drape 50 is doubled over to form a portion of a circularcovering surrounding the surgical site and generally opposite the areawhere the contact members 1 abut the surface of the beating heart. Anadditional embodiment, shown in FIG. 10B, has a surgical drape 50affixed to the outer portion of each contact member 1 a, 1 b . Whilethis configuration is not retractable, surgical drapes 50 as shown inFIG. 10B may be provided with structural support members 53 that providetensile strength and shape to the surgical drape 50 and which mayprovide supplemental stabilizing force by contacting the beating heartabout the periphery of the contact members 1 a, 1 b . An additionalconfiguration for surgical drapes 50 affixed to contact members 1 isshown in FIG. 10C where a plurality of drape supports protrude radiallyfrom several points about the periphery of the contact members 1 a, 1 band terminate in drape fastening means 54 a at their most distalportion. A portion of the drape 50 is attached to each drape fasteningmeans 54 a to spread the drape over the surgical site and may providecoverage extending in all directions outward from the contact members 1.

[0137] Referring to FIG. 11, a mechanical fixture to facilitatecompleting the anastomosis may be directly attached to the contactmember 1. A separate device to facilitate completing the anastomosis isgenerally comprised of a hinged or rotatable vessel support member 55that permits selective positioning of the source vessel 59, such as thedistal end of an internal mammary archery or the distal end of a venousor arterial graft, proximate to the target vessel 56. The vessel supportmember 55 is oriented on the contact member 1 such that the vesselsource brought into direct alignment with an arteriotomy formed in thetarget vessel 56, which is disposed between the contact members 1. Tofacilitate the completion of the anastomosis, a vessel receiving member57 is closely associated with the contact members 1 and generallysurrounds the arteriotomy in the target vessel 56. The vessel supportmember 55 has an anastomosis coupling fixture 58 that is attached to thedistal end of the source vessel and is shaped to be brought intoengagement with the vessel receiving member 57. The anastomosis couplingfixture 58 is attached to the periphery of the IMA or graft such thatwhen the vessel support member 55 is positioned proximate to thearteriotomy, the vessel receiving member 57 and the anastomosis couplingfixture 58 are brought into alignment such that a fluid communicationbetween the source vessel 59 and the target vessel 56 is establishedupon completion of the anastomosis. Completion of the anastomoses isfacilitated by an automatic suturing securing mechanism 60 or other likeapparatus for tightening the sutures to join the two vessels.Preferably, the vessel receiving member 57 and the anastomosis couplingfixture 58 are operably associated with a plurality of sutures 61 whichpenetrate the periphery of the arteriotomy formed in target vessel 56and connect the periphery of target vessel 56 to the periphery of thesource vessel 59. Thus, while simultaneously actuating the vesselsupport member 55, the automatic suturing device 60 brings the vesselsinto close conformity and completes the anastomosis procedure toestablish fluid communication between the source vessel 59 and thetarget vessel 56.

[0138] Referring to FIG. 12, a separate member for conveniently holdingthe source vessel may be provided without a dedicated apparatus forcompleting the anastomosis. A malleable wire 62 is operably affixed tothe shaft means 3 or to the contact member (not shown) and has a sourcevessel holder 63 such that the source vessel 64 may be prepared andconveniently held at a point away from the target vessel 56 until thesurgeon is prepared to complete the anastomosis. Preferably, the sourcevessel holder means 63 is comprised of a clamp for gripping andmaintaining the source vessel 64 in a preferred configuration prior tocompleting the anastomosis, such as by separating or spreading thetissue attached to the most distal portion of the source vessel 64 tomaintain the integrity and patency of the distal end of the sourcevessel 64.

[0139] As mentioned above, it is particularly preferred that theinstruments of the invention be used in a minimally invasive bypassgraft procedure wherein a minimal thoracotomy provides access to thebeating heart. A minimal thoracotomy is a small surgical openingprovided between the ribs and is formed, to the extent possible,proximate to the target artery of the beating heart where theanastomosis is to be formed. To provide access to the beating heart viathe minimal thoracotomy, the cannula may be disposed between the ribs toprovide access to the beating heart. Referring to FIGS. 13A through 13E,alternate configurations for a cannula disposed between adjacent ribsare shown. The embodiment of FIG. 13A has a cannula support bracket 67having a plurality of holes through which screws 66 may pass to providemeans to attach the assembly to the chest such as by placing the screwsin adjacent ribs 69 a, 69 b. The cannula receiving assembly 67 may haveone slot 65 formed therein such that one of the screws 66 may slidetherein for spreading the adjacent ribs 69 a , 69 b apart. The cannulareceiving assembly 67 provides an opening between adjacent ribs 69 a and69 b such that the cannula 68 may be passed therethrough. Referring toFIG. 13B, in an alternate embodiment, the cannula receiving assembly 67is replaced by a cannula 68 surrounded by a large thread means 70. Thedistal end 71 of the cannula 68 may be inserted between the ribs androtated such that the thread means 70 cause cannula 68 to be advancedbetween the adjoining ribs 69 a , 69 b , and by virtue of the expandingdiameter of the thread means 70, to spread adjoining ribs 69 a , 69 bapart while positioning the cannula 68 therebetween. In yet a furtherembodiment, in FIG. 13C, a cannula assembly 75 is provided having a clawmechanism comprised of opposing blades 73 and interlocking member 72.Adjacent ribs 69 a , 69 b are engaged by opposing blades 73, and, byforcing the cannula 68 downward, the opposing blades 73 rotate outwardsuntil a locking member 72 fixes the position of the opposing blades 73in a locked and opposing relationship as shown in FIG. 13D and 13E.Thus, by forcing cannula 68 downward, adjacent ribs 69 a and 69 b arespread apart by opposing blades 73 and the cannula assembly 75 is fixedin position by locking member 72 such that cannula 68 is positioned toprovide access to the beating heart.

[0140] A modified large diameter cannula having an extended verticalheight, may perform several functions in a minimally invasive CABGprocedure. For example, referring to FIG. 14, an enlarged cannula 74 maybe provided in the shape of an inverted cone structure having anenlarged proximal opening 76 with an enlarged diameter, and a distalopening (not shown) in distal portion 75 having a reduced diameter andwhere said distal opening 75 abuts the surface of said beating heart. Byexerting a downward force on the inverted, enlarged cannula 74, theinverted conical shape of the cannula 74 forcibly spreads adjacent ribs69 a , 69 b , and provides a stabilizing force when the distal portion75 contacts the surface of the beating heart. Surgical access to thestabilized heart is provided through enlarged proximal opening 76.

[0141]FIGS. 15A and 15B show an embodiment of the invention in use witha conventional cannula. In FIG. 15A, a conventional cannula 77 isinserted through a puncture incision in chest wall 80. The distal end ofthe stabilizing means 78 (similar to FIGS. 31A and 31B below), isintroduced in a contracted configuration through the cannula 77 to bringthe distal end thereof in contact with the surface of the beating heart79. Referring to FIG. 15B, the stabilizing means of the invention arefully inserted through the cannula 77 and manipulated to bring thecontact members 1 into contact with the surface of the beating heart 79.By manipulating handles 81 of the stabilizing means, the contact members1 are spread apart at the surface of the beating heart to provide thestabilizing function during the surgical procedure.

[0142] Where a minimally invasive procedure is employed, the means forstabilizing the beating heart of the invention are preferably providedin an embodiment where the contact members 1 that engage the surface ofthe beating heart are inserted and withdrawn from the surgical field ina position or a configuration having a reduced dimensional profile,i.e., a reduced effective diameter when inserted and removed from thethoracic cavity. For example, these embodiments are particularly usefulwhen the surgery is performed through a plurality of puncture incisions.

[0143] In the embodiment of FIGS. 16A through 16E, a pair ofrectangular, and substantially planar contact members 1 a, 1 b aredisposed within a generally cylindrical main shaft 82. In the retractedconfiguration shown in FIG. 16A, each contact member 1 a, 1 b is rolledinto a collapsed, annular configuration to reduce the effective diameterof the device by having the contact members 1 a, 1 b maintained withinthe shaft 82 when the device is inserted through an incision. In thisconfiguration, each contact member 1 a, 1 b is attached to a centralshaft 83 by a connecting shaft 2 which has a tensioning wire 84 orspring mounted to the connecting shaft 2 and the central shaft 83 todeploy each contact member 1 a, 1 b when the central shaft 83 isextended from the substantially cylindrical main shaft 82 in which thecontact members 1 a, 1 b are originally retained. Thus, in use, thecontact members 1 a, 1 b are maintained in the retracted annularconfiguration of FIG. 16A until deployed within the surgical field asshown in FIGS. 16B through 16E, by extending the central shaft 83downward causing the contact members 1 a, 1 b to be deployed below themain shaft 82. The contact members 1 a, 1 b unfold from their annularconfiguration and deploy into their substantially planar shape as shownin FIG. 16C. The contact members 1 a, 1 b rotate into position relativeto the central shaft 83 by the tension in wire or spring 84 which ispreferably disposed to act upon the connecting shaft 2 to cause contactmembers 1 a, 1 b to be fixed in a substantially parallel position to oneanother and substantially co-planar with the surface of the beatingheart as shown in FIGS. 16D and 16E.

[0144] Thus, FIG. 16A shows the contact members 1 a, 1 b in theircollapsed or retracted position. FIG. 16B shows the contact members inthe process of being deployed as the central shaft 83 is extended fromthe bottom of the main shaft 82. FIGS. 16D and 16E show the tensioningwire 84 for repositioning the contact members 1 a, 1 b in the desiredposition for use in surgery. FIG. 16C shows the central shaft 83 fullyextended from the bottom of the body of the main shaft 82 causing thedeployment of the contact members 1 a, 1 b into the desiredconfiguration for stabilizing the beating heart.

[0145] Preferably, the connecting shaft 2 joining the individual contactmembers 1 a, 1 b is hinged 85, such that upon completion of theanastomosis, the contact members 1 a, 1 b may be withdrawn by pullingthe central shaft 83 upward relative to the main shaft 82 and into thebody of the device, thereby causing the contact members 1 a, 1 b to beremovable in a low-profile configuration.

[0146] Referring to FIGS. 17A through 17D, a similar strategy as isshown in FIGS. 16A through 16E is used whereby a pair of contact members1 a, 1 b are deployed by a main shaft 86 within a hollow portion of thebody 87 of the device. In the embodiment shown in FIGS. 17A through 17D,a pair of non-flexible contact members 1 a, 1 b may be provided tostabilize the beating heart in a minimally invasive environment bycontaining the contact members 1 a, 1 b in a body or housing 87 which isinserted through the minimally invasive incision. In this embodiment,the contact members 1 a, 1 b are mounted to a central shaft 86 by virtueof a pin or hinge 88 which affixes the end of the contact members 1 a, 1b to the central shaft 86 such that the contact members 1 a, 1 b may bedeployed by rotating around the pin or hinge 88 when the shaft 86 isextended downward from the body 87 of the device. The opposite portionof the contact members 1 a, 1 b (most distal from the hinge) may fitwithin a guide fixture 89 concentrically associated with the centralshaft 86 that retains the contact members 1 a, 1 b in the desiredconfiguration prior to deployment. In use, the central shaft 86telescopes from an opening in the distal end of the body or housing 87of the device by a distance at least as great as the overall length ofthe contact members 1 a, 1 b , at which point the contact members 1 a, 1b may be deployed and locked into position, for example, in anorientation substantially perpendicular to the shaft as shown in FIGS.17A and 17C. Once fixed in position by locking mechanism 90 as shown inFIG. 17C, the central shaft 86 may be rotated using the guide fixture 89which is positioned downward to engage the contact members 1 a, 1 b .Thus, the guide fixture 89 engages the contact members 1 a, 1 b , thepin 88, or the locking mechanism 90, and by applying mechanical force,the position of the contact members 1 a, 1 b may be adjusted. Uponremoval, the central shaft 86 is withdrawn into the body 87 of thedevice. Alternatively, the housing 87 may disengage the lockingmechanism 90 from the guide fixture 89 releasing the position of thecontact members 1 a, 1 b thereby allowing the contact members 1 a, 1 bto be returned to their original or other configuration that allows thecontact members 1 a, 1 b to be drawn into the body of the device 87 tofacilitate minimally invasive removal thereof.

[0147]FIGS. 18A through 18D are an analagous-embodiment having contactmembers 1 a, 1 b retained in the undeployed configuration suitable forinsertion through a minimally invasive incision. As shown in FIGS. 18Aand 18B, the contact members 1 a, 1 b may be maintained in a retractedposition such that the length of the contact members 1 a, 1 b issubstantially parallel to the central shaft 92. The proximal end of eachcontact member 1 a, 1 b is affixed to the guide fixture 93 while thedistal end (below the hinge at central portion 91) has the bottomsurface 4 formed therein and is affixed to the distal end of the centralshaft 92. Referring to FIG. 18C, the contact members 1 a, 1 b aredeployed by the downward motion of the guide fixture 93, such that thecontact members 1 a, 1 b fold about the central portion 91. When theguide fixture 93 is fully extended downward, the contact members 1 a, 1b are formed of a pair of two-part structures wherein the lowerstructure contains the bottom surface 4.

[0148]FIGS. 19A and 19B are an additional embodiment having foldablecontact members 1 a, 1 b wherein a central shaft 94 is affixed to aplurality of hinged struts 95 that are connected to opposite ends ofcontact members 1 a; 1 b about a hinged central portion 96. When thecentral shaft 94 is extended downward, the hinged struts 95 deployoutward. As shown in FIG. 19A, the individual contact members 1 a, 1 bfold at the central hinged portion 96 to reduce the overall dimensionalprofile of the device for minimally invasive insertion or removal. Whenfully deployed (FIG. 19B), the contact members 1 a, 1 b are extendableto a substantially planar configuration as with other embodimentsdisclosed herein.

[0149]FIGS. 20A through 20E show the central shaft 97 and contactmembers 1 a, 1 b with alternate configurations for positioning thecontact members for minimally invasive insertion and removal. Referringto FIG. 20A, first hinges 98 are provided in the connecting shaft 2 suchthat the contact members 1 a, 1 b can be rotated approximately 90° outof their co-planar configuration. A second hinge 99 is provided betweenthe shaft means 3 and the connecting shaft 2 to tilt the distal end ofthe contact members 1 a, 1 b downwards as shown in FIG. 20C. Theembodiments of FIGS. 20D and 20E are modified such that twointerconnecting shafts 2 a, 2 b maintain the contact members 1 a, 1 b inslightly separate, yet parallel, vertical positions. A single hinge 100with a vertical axis of rotation allows the contact members to bebrought into close conformity before being tilted downward.

[0150]FIGS. 21A through 21C show a deployable stabilizer of theinvention having contact members comprised of a single continuous wire101 that is deployable from within a housing or body 102 which isideally inserted through a minimally invasive incision. As shown in FIG.21A, the single continuous wire 101 may be coiled and contained withinthe housing 102 such that the dimensional profile of the stabilizer isminimized for insertion. The wire 101 which forms the contact member(s)of this embodiment is preferably round and smooth, and may be formed ofa material such as Nitinol that is collapsible, and deployable into apre-determined shape. As can be seen in FIG. 21B, following insertion,the wire 101 is extended from the body 102 of the device to form atleast one loop 103 wherein at least one side 104 of the loop 103contacts the surface of the heart. Preferably, at least two loops 103extend from the body 102 of the device and are formed from a single wire101. In this configuration, maximum stabilization is achieved ifsubstantial portions of the sides 104 of both loops 103 contact thebeating heart proximate to the target vessel. As in the previousembodiments, the insertion and removal of the stabilizing device througha very small incision is least traumatic when the dimensional profile,or effective diameter, of the contact members in a retractedconfiguration is not substantially greater than the dimensional profileor diameter of the body 102 of the device. Thus, as can be seen in FIG.21C, the contact members of the embodiment of FIGS. 21A through 21C aredrawn upward by exerting force on the wire 101, the contact memberscomprised of loops 103 are drawn into a configuration which is inalignment with the body 102 of the device such that their removal may beachieved through a puncture incision with minimal additional trauma tothe patient.

[0151] In addition to a single continuous wire 101, the contact membersmay be formed of a helical wire coil 105 as shown in FIGS. 22A through22C. As in the embodiments described previously, the contact members 1a, 1 b are deployed by extending a tubular central shaft 106 through abody or housing 107 of the device to deploy the contact members 1 a, 1b. The downward motion of the central shaft 106 is terminated by thecontact between a stop 109 and the distal end of the body 107. Thecontact members 1 a, 1 b are withdrawn into the body 107 of the deviceupon completion of the surgical procedure by pulling the central shaft106 vertically through the body 107 of the device. A predetermined curvein the helical coil 105 may be provided by spacing members 108 placedbetween adjacent individual loops 105 a and 105b of the helical coil105. The central locking wires or cables may be tensioned upondeployment to increase the rigidity of the structure.

[0152] An additional configuration for minimally invasive insertion andremoval is shown in FIGS. 23A and 23B wherein the contact members 1 a, 1b are formed of an inflatable balloon 110 that is pre-shaped to provideany desired configuration of the contact members 1 a, 1 b. FIG. 23Ashows a pre-formed inflatable balloon 110 in an inflated state andextended from the housing 111. Inflation is achieved by a central shaft112 disposed within the central lumen 111. FIG. 23B shows the inflatableballoon 111 in an uninflated state for insertion or for removal.

[0153] Referring to FIGS. 24A and 24B, an inflatable contact member mayalso be provided by a cuff 113 which is positioned such that thecircumference of the cuff 113 contacts the beating heart and the ribsabout its periphery. Preferably, the target vessel 114 is positioned tobisect an annular cuff 113 to provide maximum stabilization.Additionally, referring to FIG. 24B, separate contact members 1 a, 1 b,as previously described herein, may be integrally formed with the cuff113 by mounting the contact members 1 a, 1 b in the wall of the cuff 113to extend into the interior thereof.

[0154]FIGS. 25A and 25B illustrate an embodiment of the invention whichprovides minimal trauma to the patient during insertion and removal ofthe stabilizing means by containing a simple stabilizer in an instrumenthaving a housing 115 with an extremely limited cross-section such thatthe instrument can be inserted through an extremely small incision. Inthis embodiment, the entire stabilizing means is contained within thehollow housing 115 and is comprised of a pair of contact members 1 a, 1b which are joined at the most distal end thereof. As can be seen inFIG. 25B, the contact members 1 a, 1 b are formed from a unitary shaft116 having a divided portion 117 at the distal end such that upondeployment from the housing 115 of the device, the divided portion 117splits into two contact members 1 a, 1 b joined at their most distal tip118 and which may be brought into contact with the beating heart alongthe divided portion 117 of the unitary shaft 116.

[0155] In addition to the friction means or cushioning members describedabove in FIGS. 1B through 1G and FIG. 3, sutures may be used to attachor position epicardial tissue relative to a contact member 1 to enhancethe stabilization function of the invention and to position epicardialtissue or the target vessel of the anastomosis. FIG. 26A, 26B, and 26Care embodiments where means for fixing the position of epicardial tissueis comprised of sutures 119 used in combination with the contact members1 a, 1 b to stabilize and position tissue surrounding the site of ananastomosis and the target cardiac artery. In FIG. 26A, a series ofsutures 119 is placed through the epicardial tissue (not shown) andlooped around the contact members 1 a, 1 b to effectively positionseveral points on the surface of the beating heart in fixed relationshipto the contact members 1 a, 1 b. In FIG. 26B, the contact members 1 a, 1b and optionally the shaft means 3 associated therewith have passages120 formed therein through which a suture line 119 may be passed. In theparticular example of FIG. 26B, a single suture 119 is passed throughthe body of the shaft 3, exits from within the first contact member 1 athrough a passage 120 formed therein, passes underneath the targetvessel 121, emerges from an opposite side of the target vessel 121, andenters a passage 120 in the opposite contact member 1 b joined to thefirst contact member 1 a by the connecting shaft 2. The suture 119 exitsthe opposite contact member 1 b again passes beneath the target vessel121, reenters the first contact member 1 a at a separate passage 120,and passes through the body of the first contact member 1 a and into theshaft means 3. In this configuration, the suture lines may bemanipulated by the surgeon from a remote location, such as external tothe incision in the chest, to remotely position the vessel by drawingtension on the suture line 119. FIG. 26C shows a similar arrangement forthe suture line 119 as in FIG. 26B, however in FIG. 26C, apertures 122in the body of the contact member 1 are used to select the direction ofthe suture 119 rather than having passages 120 which traverse the bodyof the contact member 1. Also; in this or the other embodiments, aseparate sliding shaft 123 may be provided that gathers and is traversedby the sutures 119. The step of drawing tension on the suture line 119is facilitated by advancing the sliding shaft 123 to abut the contactmember 1 and exerting a small downward force on the sliding shaft 123while exerting an upward force to draw tension on the suture line(s)119. By maintaining downward force on the sliding shaft 123, the targetvessel 121 is raised while the potential for displacing the contactmember 1 is minimized because the upward force exerted on the suturelines 119 is countered by the downward force exerted on the slidingshaft 123.

[0156] Referring to FIGS. 27A and 27B, a modification of the contactmember 1 of the invention may be provided by a structure formed at thedistal end of the shaft means 3 and which is inserted directly into thearteriotomy 124 formed in the target vessel 125. This intravesselstabilizer 126 has a body designed to fit conformingly about theinterior of the target vessel 125, and may be in communication(including fluid communication) with a hollow portion of the shaft means3. The body 126 of the intravessel stabilizing means may be asubstantially cylindrical lumen as shown in FIG. 27B and should have anoverall length which is greater than the length of the incision creatingthe arteriotomy 124. Additionally, in the embodiment of FIG. 27B, theintravessel stabilizer 126 may be perpendicular to the shaft means 3 andhave cuffs 127 at the distal end of the body 126 to provide conformingengagement with the interior of the target vessel. As shown in bothFIGS. 27A and 27B, this embodiment of the stabilizing means of theinvention is preferably used in connection with a plurality of sutures128 that penetrate the edges of the target vessel about thecircumference of the arteriotomy 124. By exerting pressure on the shaftmeans 3 and the plurality of sutures 128, the target vessel isstabilized, and its position may be manipulated, to facilitatecompletion of the anastomosis.

[0157] In addition to stabilization of the beating heart proximate tothe target vessel of the anastomosis, additional fixtures, structures orelements associated with the contact members 1 can be used to retract orfix epicardial tissue proximate to the target vessel and the site of theanastomosis by using a means for gripping epicardial tissue at thesurface of the exterior of the heart. The means for gripping may beprovided by several different embodiments. For example, FIG. 28A shows afunctional clamp 128 formed by a crimping contact member 1 that has afold 129 disposed longitudinally at the center of the length of thecontact member 1. When force is applied to the sides of the contactmember 1 opposite the fold 129, the crimping action of the contactmember 1 grasps the epicardial tissue 130 at the heart surface 131 andcontains it within the folded contact member 132. In another embodiment,as shown in. FIG. 28B, a plurality of open passages 133 are provided ina contact member 1 that has a slidable member 134 disposed within a slot135 formed within the contact member 1. When sufficient force is exertedin a downward direction on shaft 3 to force epicardial tissue 130through the open passages 133, the slidable member 134 then may beactuated to grip the tissue 130 contained within the open passages 133.By gripping a portion of epicardial tissue 130, the tissue may be spreadto more readily expose the target vessel 136 of the anastomosis.

[0158] A similar function is provided by a pair of contact members 1that are formed of circular rollers 137 that lie longitudinally parallelto the direction of the target vessel 136 as shown in FIGS. 29A and 29B.The contact members 1 may be comprised of movable rollers 137, belts, orpivoting surfaces that may be rotated independently about an axis 138dedicated to each contact member 1 such that the epicardial tissue 130is gathered or spread, depending on the respective directions ofrotation of the rollers 137, as desired at the surface of the heart toexpose the target vessel 136. As will be apparent to those skilled inthe art, each of these embodiments may be provided with contact members1 that are independently movable in a parallel, V-shaped, or otheradjustable configuration as described and illustrated herein.

[0159] Referring to FIG. 30, the contact members 1 may be furthercomprised of a spring-tensioned frame 139 having a movable frameextension 140 which may have pins or an associated friction means 4 atthe bottom surface 4 of the contact members 1 a, 1 b to engage thetissue proximate to the target artery. The movement of the frameextension 140 is tensioned by a spring means 141 which draws the frameextension 140 toward the contact member 1 after the frame extension 140has been manually positioned to engage the tissue. The use of thisembodiment of the invention is the same as is described for the otherembodiments herein, with the frame extension 140 providing the improvedexposure of the target artery by retraction of the epicardial tissue. Aswith the other embodiments, the contact members 1 may be attached at oneend by a connecting shaft 2 which is attached to a shaft means 3 asdescribed above. The connecting shafts 2 may also be positioned relativeto one another by a conventional threaded post 142 with a positioningthumbscrew 143.

[0160] Referring to FIGS. 31A and 31B, the stabilizer means may also becomprised of a single shaft means 3 connected to each contact member 1.In a preferred embodiments the shaft means 3 are interconnected at anintermediate pivot point 144 which permits the contact members 1 to becontinuously positioned in parallel fashion relative to one another. Theproximal (upper) portion of the individual shaft means 3 may have gripsadapted to be grasped by the hand or may have an anchor portion 145 forattachment to a retractor or other fixed support. As with the otherembodiments described herein, the length of the shaft means 3 may beadjustable by a conventional telescope configuration. In such aconfiguration, a first shaft 148 has a partially hollow segment 147adapted to receive the complimentary portion of the second shaft 148.Either first 146 or second 148 shafts may be connected to the contactmembers 1 and may each have a conventional interlocking-mechanism 151 tofix the relative positions of the shafts. The shaft means 3 may alsohave a tensioning spring mechanism 150 having an axis 149 which isdisplaced between a portion of the shaft means 3 affixed to the contactmembers 1 and the remainder of the shaft means 3. In this configuration,the contact members 1 remain tensioned against the heart proximate tothe anastomosis site when the proximal end of the shaft means 3 isaffixed to a stable support. This embodiment also preferably has afriction means as described above affixed to the bottom surface 4 ofeach contact member 1. An additional advantage of this embodiment isderived from the capability to move the contact members 1 apart from oneanother in a parallel configuration. Thus, the contact members 1 canfirst be positioned to engage the surface of the heart tissue, followedby the application of a stabilizing force in combination with spreadingor joining of the proximal (upper) end of the shaft means 3. Applicationof a stabilizing force causes the tissue on either side of the targetartery to be spread or compressed while the heart is stabilized. Thus,by coincidentally spreading or joining the proximal portion of the shaftmeans 3, the epicardial tissue engaged by the contact members 1 isstretched or compressed to provide stabilization and improved exposureand positioning of the target coronary artery.

[0161] Referring to FIGS. 32A through 32C, the contact members 1 mayhave associated therewith additional structures which serve to positionor retract epicardial tissue, at or around the surface of the heart,particularly tissue in the vicinity of the site of the anastomosis.Often, the surgeon wishes to retract the epicardial tissue near thetarget vessel to increase exposure of the vessel where the anastomosisis to be performed. Additionally, these associated structures provide anadditional amount of stabilization by actually penetrating the tissue atthe outer layer of the heart and holding the tissue in close conformityto the contact member.

[0162] Referring to FIG. 32A, epicardial tissue retractors are providedby a series of curved pins 152 which generally extend from one contactmember 1 a to the other 1 b by virtue of a guide 153 attached to thebottom of each contact member 1 and which is dedicated to a single pin152. In this embodiment, a plurality of pins 152 are substantiallyparallel to one another and may be inserted and positioned to passbeneath the vessel where the anastomosis is to be performed. In thisfashion, the surgeon can position the vessel, by virtue of the tissueengaged by the pins 152 and the contact members 1 a, 1 b in anydirection. This embodiment is particularly useful to vertically displacethe tissue, i.e., in a direction perpendicular to the shaft means 3.

[0163] An additional embodiment is shown in FIG. 32B, whereby aplurality of short pins 154 extend down from the bottom surface 4 of thecontact member 1 to enter the epicardial tissue. The short pins 154 mayextend in a direction substantially perpendicular to the surface of thetissue and the bottom surface 4 of the contact member 1, or may beangled outward to engage the tissue. The advantages of this embodimentare best utilized with a stabilizing means wherein the individualcontact members 1 a, 1 b may be selectively positioned such that thedistance between the individual contact members is varied. Thus, thecontact members 1 a, 1 b can be brought into contact with the surface ofthe beating heart followed by spreading the contact members 1 a, 1 bapart from one another to provide retraction and spreading of theepicardial tissue. This is readily achieved in the embodiment of FIG.32B, wherein a single shaft means is dedicated to each contact member 1a, 1 b, respectively and the individual shafts are joined by anintermediate pivot point 155.

[0164] A similar embodiment is shown in FIG. 32C, however, in thisembodiment, while each contact member 1 a, 1 b has a dedicated shaft,the shaft 156 dedicated to the first contact member 1 a is disposedwithin a hollow shaft 157 dedicated to the second contact member 1 b. Inthis configuration, each shaft 156, 157 may be individually rotatedabout the other to provide a V-shaped retraction of the epicardialtissue. In this embodiment, the epicardial retractor pins 154 arepreferably similar in structure and orientation to the embodiment ofFIG. 32B. The pins in both designs could alternatively be curved orangled inward, and the contrast members 1 moved toward each other,providing a compression of the epicardium to stabilize the tissue andpresent the anastomosis site to best advantage. This action may alsoserve to occlude the blood flow in the coronary artery, minimizing bloodloss and obstructions of the visual field.

[0165] Referring to FIGS. 33A and 33B, the stabilizer means may compriseat least one stabilizer plate which is attached to a stable support bythe shaft means 3 and which may be used with a lever member 158 forimproving exposure at the target artery while the anastomosis iscompleted. In this embodiment, the means for stabilizing the beatingheart comprises a left and right stabilizing plate 159, 160 which areoriented to exert a downward force on the epicardial tissue at eitherside of the target artery at the anastomosis site and which may besubstantially planar or may be curved to conform to the surface of theheart. One or both of the stabilizing plates 159, 160 may have an edge161 deflected downward along its length so that the edge 161 depressesthe tissue proximate to the artery to increase the exposure of theartery during the completion of the anastomosis. Preferably, the edge161 of the stabilizing plates 159, 160 has a separate lever member 158running substantially parallel to the artery and on both sides thereof.The top portion of each lever member 158 contacts the underside of thestabilizing plates 159, 160. In this embodiment, the lever member 158 issubstantially cylindrical, traverses the stabilizing plate along itslength, and is oriented to be parallel to the edge 161 of thestabilizing plate 159, 160. The lever member 158 is fixed in place, andmay be affixed to the heart by a suture. In such a configuration, eachof the stabilizing plates 159, 160, which is in contact with the levermember 158 along its length, contacts the heart such that the edge 161depresses the tissue on both sides of the target coronary to restrictthe movement of the beating heart. The stabilizing plates 159, 160 canbe attached to one another or can move independently as desired.

[0166] Opposite the edge 161, at a point separate from the lever member158, the stabilizing plates 159, 160 are connected to a shaft means 3which holds the stabilizing plates 159, 160 in position and which may bemanipulated relative to the lever member 158 to cause the edge 161 toengage the heart. The shaft means 3 is preferably affixed to eachstabilizing plate 159, 160 at a point opposite the edge 161 and removedfrom the point where the lever member 158 contacts the stabilizer plates159, 160 at a location to maximize leverage when the stabilizer plates159, 160 are drawn upwards at the point of attachment of the shaft means3. The shaft means 3 may be constructed as described elsewhere hereinand should be of sufficient length to facilitate manipulation of theshaft means 3 by the surgeon. As noted, the shaft means may also beattached to the retractor to fix movement of the stabilizing plates 159,160 during the procedure.

[0167] In a preferred embodiment, the length of the shaft means 3 isadjustable relative to the retractor or other stable support. Forexample, the shaft means 3 may be telescopic as described above or maybe comprised of a hollow post 163 which receives a rigid shaft 164 whichis in turn fixed to the retractor. The rigid shaft 164 may also besubstantially hollow and may have a suture or other line 165 passedtherethrough and which also passes through the length of the hollow post163. In this configuration, one end of the suture or line 165 isattached to the stabilizing plates 159, 160 and the other end extendsthrough the hollow post 163 or the rigid shaft 164 to a position whereit may be manipulated by the surgeon. The position of the stabilizingplate 159, 160 may thereby be remotely actuated. By drawing tension onthe suture or line 165, the stabilizing plate 159, 160 pivots about thelever member 158 and the edge 161 of the stabilizer plates 159, 160depress the tissue on either side of the target artery.

[0168] Referring to FIGS. 34A through 34E, a lockable mechanism may beprovided to depress tissue on either side of a target vessel by amovable edge 176 formed along the edge of a block 177 which rotatesabout a support member 178 by means of a hinge pin 179. The supportmember 178 may be affixed to the upper surface of a contact member asdescribed herein or may itself comprise the contact member. In use, asshown in FIG. 34B, the block 177 is rotated about the support member 178using hinge pin 179 until the movable edge 176 contacts the surface ofthe heart parallel to the target vessel 180 (FIG. 34C). The moveableedge 176 and block 177 are fixed in place by depressing locking member181 to force the block 177 to rotate until an interconnecting member 182extends the block 177 and edge 17 to fully depress the tissue proximateto the target vessel 180. At this point, and shown in FIG. 34D, thelocking member 181 fixes the interconnecting member 182 in an extendedposition and is locked in place (FIG. 34E). The position of the block177 may be released by actuating the locking member 181 to release theinterconnecting member 182.

[0169] Due to the fact that the heart continues to beat during the CABGprocedures described herein, features of the invention which provide thecapability to manipulate the target vessel, and to control the flow ofblood therein, may greatly facilitate an efficient completion of theanastomosis. For example, additional components associated with thecontact members 1 may be used to occlude the target vessel during theanastomosis procedure. Any of a variety of fixtures may be provided tooperate in association with the contact members of the invention inorder to occlude the vessel that is the target of the anastomosis.

[0170] Referring to FIG. 35, a stabilizing means 166 is comprised of acontact member which is substantially planar and has a substantiallyrigid surface 167 having a centrally disposed opening 168 in which thetarget artery of the anastomosis is positioned longitudinally throughthe opening. At either or both ends of the centrally disposed opening168, an occluder 169 extends below the surface 167 and engages thetarget artery to substantially reduce or eliminate the flow of bloodthrough the artery. The occluder 169 is a deformable member having asmooth outer surface for adjustably contacting and depressing the targetartery without damaging the tissue. The planar surface 167 of thestabilizing means also has an aperture 170 comprising an opening whichtraverses the entire planar surface 167 so that the graft can be passedthrough the aperture 170 when the anastomosis is completed. The planarsurface 167 may also provide a mounting surface for springed tissueretractors 171 comprising a coiled spring 172 attached to the planarsurface at one end and having a hook or pin 173 at the opposite end toengage and spread the tissue proximate to the anastomosis site toimprove the exposure of the target artery. The planar surface 167 isattached to a post 174 which may be attached to a stable support such asa rib retractor. The planar surface 167 may also have at least one port175 for receiving a suture line.

[0171] Referring to FIG. 36, the stabilizing means may have operablyassociated therewith an artery occluder 183, which is preferablyattached to the contact members 1 or to the connecting shaft 2. Theartery occluder 183 may comprise a semi-rigid member which has a bluntportion 184, which may be positioned such that the blunt portion 184engages the target artery 185 and compresses the target artery 185 to apoint causing occlusion of the target artery 185 passing between thecontact members 1 such that the blood flow through the artery issubstantially reduced or eliminated. Preferably, the occluder 183 has ashaft portion 186 which traverses the connecting shaft 2 such that theblunt portion 184 of the occluder may move from above the level of thetarget artery 185 to a point below the level of the original vesselsufficient to occlude the blood flow through the vessel.

[0172] Referring to FIG. 37A, a concentrically movable shaft 187 isdisposed within the shaft means 3 to which the contact members 1 areconnected. In this embodiment, the target vessel 188 is positioneddirectly between and parallel to the longitudinal or greater length ofthe contact members 1. When so positioned, the concentric shaft 187within the main shaft means 3 may be pressed downward such that thedistal end 189 of the concentric shaft 187 encounters the vessel 188 andcompresses the vessel, thereby occluding the vessel 188 to substantiallyprevent the flow of blood therethrough. This embodiment has theadvantage that the amount of occlusion is continuously variable byvarying the force applied and the distance by which the concentric shaft187 is depressed relative to the shaft means 3. FIG. 37B is a similarembodiment of the invention whereby a means for occluding the vessel isaffixed directly proximate to the contact members 1. In the example ofFIG. 37B, a pushbolt 190 is disposed on the connecting shaft 2 thatjoins opposing contact members 1 and is generally positioned in a raisedportion thereof such that when the pushbolt 190 is not deployeddownward, the vessel remains in its native position when orientedbetween the contact members 1. Occlusion of the vessel 188 is achievedby pressing the pushbolt 190 down until the lower portion 191 engagesthe vessel 188 when the vessel 188 is disposed between the contactmembers 1. This embodiment provides the ability to occlude the vessel188 both proximal and distal to an arteriotomy 191 in the target vessel188 at the site of the anastomosis. Referring to FIG. 37C, a similarembodiment is provided by a roller 192 or clip mechanism 193 which isaffixed to one or both contact members 1, for example by a binge 194,which is selectively movable, to contact the target vessel 188 at apoint either proximal or distal or both to the arteriotomy.

[0173] In addition to positioning the target vessel for performing theanastomosis as shown in FIGS. 26A through 26C above, sutures associatedwith the stabilizer may be used to occlude the vessel to permit theanastomosis to be performed in a bloodless field. Referring to FIGS. 38Aand 38B, an embodiment of the invention may have a flange 195 protrudingfrom the contact member 1 to permit silastic vessel loops or sutures 196to be drawn about the target vessel 197 and the flange 195. To occludethe vessel 197 the suture 196 is passed around the vessel 197 and drawntight around the flange 195. To facilitate occluding the vessel, asliding shaft 198 may be used to surround the sutures 197 such that thesuture lines 196 traverse the length of the sliding shaft 198 and extendout the bottom to surround the vessel 197. In one embodiment, as shownin FIG. 38B, the shaft 3 of the stabilizing means has a movable rod 198a having suture guides 199 disposed therein or operably associatedtherewith for adjusting tension on the suture lines. The movable rod 198a may be concentrically disposed within the shaft means 3 such thatdownward pressure on the shaft means 3 and upward pressure on thesliding shaft 196 draws tension on the sutures 196 to occlude the vessel197.

[0174]FIG. 39 shows modifications to the upper surface of contactmembers 1 a, 1 b of the invention wherein fixtures 201 are adapted toprovide a resting place or attachment point for other surgicalinstruments such as scissors 202, forceps 203, or sutures and sutureneedles 204. Preferably, the fixtures 201 are magnetic to facilitateretaining metallic surgical instruments im conforming contact with theupper surface of the contact member 1.

[0175] Referring to FIG. 40, the contact members 1 of the inventionand/or the shaft means 3 to which the contact members 1 are attached maybe provided with one or more flexible joints 205 that permit positioningof either the contact members 1 or the shaft means 3 about an axis.Preferably, the flex joint 205 may be provided at the point where theshaft 3 engages the contact member 1 (not shown), at the point where theconnecting shaft 2 engages the shaft means 3, or at the point where theconnecting shaft 2 is attached to the contact members 1.

[0176] Thus, in the embodiment of FIG. 40, the flexible joint 205provided at the point where the connecting shaft 2 is attached to eachcontact member 1 allows the connecting shaft 2 and the shaft means 3 tobe tilted about an axis which is perpendicular to the target vessel. Theflexible joint 205 provided at the point where the shaft means 3 isattached to the connecting shaft permits the shaft 3 to be tilted fromside-to-side relative to the connecting shaft 2. In the embodiment ofFIG. 40, or in the embodiments described herein having hinges orflexible joints, the hinges or flex joints may be replaced byconventional lockable joints 206, as shown in FIG. 41, that areselectively locked and unlocked mechanically as with forceps 207.

[0177] As can be seen, such occluders are similar to the stabilizingcontact members 1 described in several other embodiments herein, and canbe expected to provide significant stabilization of the beating heart.These occluders can be used in conjunction with other stabilizing meansor independently. They may be placed beside, rather than upon, thecoronary artery to provide stabilization without occlusion, if desired.In like fashion, most of the contact members 1 of other embodiments willprovide some occlusion of blood flow if placed upon, rather than beside,the target vessel.

[0178] As will be described in individual embodiments below, the shaftmeans 3 may be attached, to or comprised of, a conformable arm which isused to position the contact members against the heart, and then to lockthe stabilizing means in place once a stabilizing force has beenexerted. The conformable arm is flexible and lockable and may haveseveral configurations including a plurality of links, segments, oruniversal joints in serial configuration and having a cable fixturepassed through the interior of the links which causes the entireconformable arm to become rigid by tightening the cable fixture. Also,the conformable arm may be comprised of a synthetic gel or polymercontained within a conformable cylindrical housing and which becomesrigid upon exposure to light or heat, such as the commercially availableDymax 183-M. Where the shaft means 3 is further comprised of theconformable arm, the conformable arm may be attached directly to theconnecting shaft 2 or the contact members 1.

[0179] Referring to FIG. 42, this embodiment of the invention is a meansfor stabilizing the beating heart wherein the shaft means is comprisedof a flexible, lockable arm 208 having a plurality of interconnectinglinks 209 which allow positioning of the flexible arm 208 in everydirection until the desired configuration is achieved at which point theflexible arm 208 may be locked into fixed configuration by tightening acable fixture (not shown) attached to a cable 210 running axiallythrough the interconnecting links 209. Each interconnecting link iscomprised of a ball portion 211 and a receiving portion 212 such thatthe ball portion 211 fits conformingly within the receiving portion 212.The proximate (uppermost) end of the flexible, lockable arm 208 can beattached to a stable support, or to the retractor. In a preferredembodiment, the flexible, lockable arm 208 is a series ofinterconnecting links 209 having a cable 210 running through the centerof each interconnecting link 209 such that when tension is exerted onthe cable 210, the flexible, lockable arm 208 is fixed in a rigidposition. FIG. 42 also shows an embodiment of the invention wherein thecontact members 1 are comprised of a pair of substantially parallelelements 1 a, 1 b which are positioned to receive a simple snap fixture213 which is affixed to the surface of the heart. In this embodiment,the snap fixture 213 is positioned between the two parallel elements 1a, 1 b of the contact member 1, in order to fix the position of theheart tissue relative to the contact members 1. As in the aboveembodiment, the contact members 1 are preferably oriented in asubstantially parallel fashion with the target artery of the anastomosispassing therebetween. The snap fixtures 213 are affixed to the heart bya suture, wherein the suture line 214 may then also be attached to thecontact member 1 via a notch, which may form a one-way locking mechanismto secure the suture line 214, or may be attached to a circular postdisposed in the body of the contact member 1 (not shown). The sutureline 214 then maybe tied through the notch or to the post in the contactmember 1, to the contact member 1 a, 1 b itself, or to the connectingshaft 2 to more tightly secure the heart to the contact member 1. Anadditional advantage of this embodiment is that the stabilizing means isactually affixed to the cardiac tissue via the suture line 214, suchthat when the heart is moving laterally or downward the artery beingstabilized remains immobile and the surface of the heart may be liftedusing the shaft means 3.

[0180]FIG. 43 shows an alternate embodiment of the flexible lockable arm208 attached to a retractor blade 279 and having a series ofinterconnecting links comprised of sphere joints 215 and cylindricaltubes 216 and which may have a tensioning cable traversing the length ofthe flexible, lockable arm as in the design of FIG. 42. Additionally,these embodiments may have other tensioning means such as an inflatableinternal balloon 217 that expands against the interior of the linksrendering the individual links immobile, and thereby locking the entirearm 208 into a fixed position.

[0181] Additionally, the flexible, lockable arm 208 may be provided by aplurality of curved or bent tubular segments 218 as shown in FIG. 44Athat are interconnected by an internal tensioning cable 210 or othertightening means. In the embodiment of FIG. 44A, the curved or benttubular segments 218 have interfacing surfaces 219 with teeth 220 suchthat when brought into conforming relationship, the curved tubularsegments 218 do not rotate relative to one another due to theinterlocking relationship of the teeth 220 See FIG. 44B. As above, theflexible lockable arm 208 is fixed in position by applying tension via acentrally disposed tensioning cable 210 or other tensioning means suchas a spring-loaded rod, bolt, or wire. The interconnection betweenadjoining segments 218 may also be facilitated by brushings 221 that aredisposed around the wire 210 and are shaped to fit within a recessedportion 222 of interfacing surface 219.

[0182] Referring to FIG. 45A, a continuously flexible, lockable arm 208is provided by a hollow flexible shaft 223 having a material 224disposed within which may become semi-rigid or stiff by a variety ofmethods. In use, the contact members 1 are positioned at the desiredorientation relative to the beating heart, and the material 224 insidethe flexible shaft 223 is caused to be rendered stiff or semi-rigid. Thematerial 224 disposed within the flexible shaft 223 may be an epoxy-typeglue, a low melting temperature metal with an electric heating wire 225disposed therein, a fine granular material or known chemicals whichbecome semi-solid upon exposure to light, heat, or chemical means. Wherea fine granular material is used, a mechanical compression fixture 226or vacuum suction may be provided to compress the material 224 to causethe shaft 208 to become rigid.

[0183] Referring to FIG. 45B, additionally disposed within the flexibleshafts 223 may be a plurality of interconnected discs 227 which aresubstantially parallel and which engage the inner-surface of theflexible shaft 223. As with the above-described embodiments, the discs227 may be interconnected by a wire 210 running the length of the shaftThe plurality of discs 227 reduce shear forces across the flexible shaft223 and may provide separately activated sections that provide forselective stiffening of the flexible shaft along its length. As would beapparent to one of ordinary skill in the art, a flexible lockable shaftmay be provided by a hybrid of the various embodiments described herein,such that selective portions of the shaft may be rendered more or lessflexible as desired.

[0184] Referring to FIG. 46A, an adjustable shaft means 3 may also beprovided by a plurality of adjustable links 228 that are connected to,or comprise, the shaft means 3. Preferably, the adjustable links 228 arepositioned at the distal end of shaft means 3 and are connected to theconnecting shaft 2, or directly to the contact members 1. Referring toFIG. 46A, a plurality of curved or bent links are provided, preferablyat least three such links, which are independently adjustable to providemultiple rotational adjustments. The plurality of adjustable links 228provides a compact mechanism for positioning the contact members 1throughout a wide range of motion.

[0185] Referring to FIG. 46B, the links are independently rotatablerelative to the shaft means 3 and the shaft 2 connecting end contactmembers 1 and to each other. The assembly formed of the plurality ofconnected links may be lockable by providing an elastomers liquid or gasshredded elastomer rubber, granulated plastic, or tint rubber metallicball bearings hydraulic medium within the body of the links 228.

[0186] Referring again to FIG. 46A, an elastomeric hydraulic medium 229is disposed within the adjustable links. The point of interconnectionbetween the adjustable links may have internal or external retainingrings 230 a, 230 b and a means for compressing the elastomeric hydraulicmedium 229 that is operably associated with the interior of theadjustable links 228 such that a force can be exerted on the medium 229to pressurize the medium to lock each link 228 against the retainingrings 230 a, 230 b to fix the position of each adjustable link 228relative to the adjoining link, thereby locking the entire assembly ofthe shaft means 3 into position.

[0187] Referring to FIG. 46C, a means for compressing the elastomerichydraulic medium may be provided by a pushrod 231 that encounters themedium at its distal end, and which may be actuated by a handle 233attached to a screw 232 at the proximal end of the shaft means 3. Thehandle 233 has a spring 234 disposed about a piston to maintain aconstant small force upon the medium 229. The compression spring 234 inthe proximal end of the shaft 3 provides a minimal preloaded force onthe pushrod 231 in the same direction as when the handle engages thepushrod with screw 232. The force provided by spring 234 allowsrepositioning of the contact members 1 in a non-locked state.Additionally, the handle 233 is threaded into a housing 236 which is inturn threaded onto the shaft 3. Rotating the housing 236 on the threadedshaft 3 provides for an adjustment in the length of the shaft which intun will adjust the preload force that the above-mentioned springmaintains, as well as, the axial position of the handle 233.

[0188] A flexible shaft may also be provided by the embodiment of FIG.47 having a plurality of substantially unstretchable strands 239contained within a flexible outer shaft 240 that has a locking meanscomprised of clamp 241 at the proximal end for compressing the strands239 at the proximal end and thus fixing the position of the flexibleshaft. Thus, by actuating the locking means comprised of clamp 241 thestrands 239 within the flexible shaft 240 are compressed against oneanother, preventing an individual strand from sliding relative to oneanother, thereby fixing the position of the plurality of strands 239 andlocking the contact members 1 in place.

[0189] The interior of the flexible shaft 240 may be provided withseveral flexible substances which may be rendered solid by chemical ormechanical means or may have sealed portions that cause the flexibleshaft 240 to become rigid or semi-rigid. For example, FIG. 48 has aflexible shaft 240 with a cable 210 running along its length andplurality of fluid-filled lumens 242 disposed therein. When the lumens242 are not sealed, the contact members 1 may be continuously positionedand the flexible shaft 240 set in any configuration. When the desiredorientation of the contact members 1 is achieved, the lumens 242 aresealed to fix the position of the flexible shaft 240. Additionally,these lumens 242 may be differentially pressurized or evacuated toadjust the position of contact members 1.

[0190] Referring to FIG. 49, a fine adjustment mechanism is provided bya plurality of threaded positioning cables 248 that traverse threadedports 244 of a proximal portion 243 of the shaft means 3 and about theperiphery of an end member 245 of the shaft. The end member 245 of theshaft 3 is positioned at each of the plurality of threaded ports 244 byturning the threaded cables 246. By rotating the cables by knobs 247,the portion of the end member 245 of the shaft is moved either upward ordownward relative to its original position.

[0191]FIG. 50A shows the interior of a shaft means 3 of the inventionhaving a spring-loaded mechanism 249 in the proximal portion thereof fordamping the vertical motion of the proximal end of an inner shaft 251. Aspring 252 is mounted within the interior of the proximal portion 253 ofan outer shaft 254 such that when the contact members 1 are lowered ontothe beating heart, the proximal end of inner shaft 251 gently compressesthe spring 252. The outer shaft 254 may be positioned downward until apoint of resistance is met at which the beating heart achieves adequatestabilization. At that point, the outer shaft 254 may be fixed inposition, i.e., by attaching to the retractor or other stabilizedsupport 255 while the inner shaft 251 may move up and down in a verticaldirection. The oscillation of the inner shaft 251 is dampened by thespring 252 mounted in the proximal portion 253 of the outer shaft 254 ormay be rendered motionless by lower positioning of the outer shaft 254relative to the surface of the beating heart.

[0192] As shown in FIG. 50B, the spring mechanism 249 may also bemounted at the distal portion of the shaft means 3 and the spring 252may be external to a central shaft 256. An additional configurationhaving a damped vertical motion is provided by a fluid-dampeningmechanism consisting of a chamber 257 having a plunger 258 for movingtherein wherein said plunger has a piston 261 having an annular seal 261a thereabout, such as a rubber O-ring seal, that engages the internalportion of the chamber 257 to substantially seal the passage of fluid.Piston 261 has one or more orifices 269 to restrict the flow of fluidtherethrough. Additionally, inside plunger 258 is a one-way valve suchas a spring-loaded ball 258 a within a bypass passage 258 b. As anupward vertical force is imparted upon the central shaft 250, the fluiddampening mechanism restricts the ability of the central shaft 250 tomove upward, while its downward motion is relatively unrestricted, dueto fluid flowing trough bypass passage 258 b.

[0193] Referring to FIG. 51A, the shaft means 3 depicted therein has anadjustable central shaft 263 with a fine adjust capability provided by athumbscrew 264 which is rotatable about a threaded portion 265 of thecentral shaft 263 and which is connected at the most distal end to thecontact members 1. Independent rotation of the central shaft 263 isprevented by a stop 268. As in FIG. 1, the shaft of this embodiment maybe rotatably attached to a portion of a retractor or stabilized support266 by passing the shaft through a ball and socket joint 267.

[0194] Referring to FIG. 51B, the contact members 1 are attached to apartial portion of the shaft means 3 comprised of an outer sleeve 269that extends to engage a second shaft 270 having a plurality of splines271 about the exterior. A first internal shaft 272 is attached to a balljoint 273 operably connected to the contact members 1. The firstinternal shaft 272 is disposed inside both the outer sleeve 269 and thesecond shaft 270 and has threads 274 to permit adjustment by a handle275 (which may be removable). At the end of the threaded internal shaft272, the ball joint 273 allows the contact members 1 to rotate at thebase of the shaft means 3. The second shaft 270 is engaged through theouter sleeve 269 by the splines 271 to keep the ball joint 273 fromrotating. A circular clip 276 has inner ridges 276 a that pass throughthe outer sleeve 269 and maintain the ball joint 273 in a fixedposition.

[0195] Referring to FIG. 52, a method for providing continuous andadjustable positioning of the contact members 1 of the invention may bereadily provided by a malleable shaft 277 which is attached to thecontact members 1 and which may slide and be molded by hand. Inparticular, the malleable shaft 277 may slide through a fixture 278attached to a stable support such as a retractor blade 279 used to openthe surgical incision. The vertical positioning of the device may beachieved by a handle 280 which is manipulated from outside of theincision and causes a vertical portion 281 of the malleable shaft 277 toslide through the fixture 278.

[0196] Referring to FIG. 53, an embodiment for the shaft means 3 of theinvention is shown having a plurality of linked members 282, each ofwhich is connected to the adjacent linked member 282 by a hinge 283, anda torsion spring connected to each hinge (not shown) and which areinterconnected by a cable 284 connected to each linked member 282,preferably at an attachment point 285 adjacent to the hinges 283. Byproviding a plurality of discrete interconnected linked members 282 withan arcuate shape, and by providing an interconnecting cable 284, acurved shaft means 3 is provided with the ability to coil and uncoil asthe tension is exerted, released, or reversed, on the cable 284.Preferably, the most distal linked member 282 and the end of the cable284 is affixed to contact member(s) in any of the several embodimentsdescribed previously.

[0197] To take advantage of the minimally invasive procedures enabled bythe invention, the positioning of the contact members 1 by manipulationof the configuration of the shaft means 3 may be achieved remotely,i.e., from outside the incision, by any of a variety of mechanismsattached to and operably associated with the shaft means 3. Referring toFIGS. 54A through 54C, remote manipulation of the positioning of thecontact members 1 may be provided by a shaft means 3 having a ball joint286 at the distal end thereof which is connected to the contact members1 or the connecting shaft 2. Continuous positioning of the ball joint286 may be provided by a plurality of cables 287 which are affixed tothe ball joint at opposing points 288 at the exterior surface of theball joint 286. The ball joint 286 is maintained in a socket 289 at thedistal end of the shaft means 3. The shaft means 3 itself may be rigidor flexible, or may be fixed into a pre-determined position by thesurgeon depending on the clinical environment. Additionally, the shaftmeans 3 may be comprised of a plurality of shafts, including an innerflexible shaft 290 contained within a rigid shaft 291 wherein theflexible shaft 290 extends above the rigid portion, terminating at thepositioning handle 292. The contact members 1 are positioned by means ofthe plurality of cables 287 attached to the ball joint 286. Theplurality of cables 287 runs from the ball joint 286 through the lengthof the shaft means and terminate in a positioning handle 292 at theproximal end of the shaft means 3. The shaft 3 may be of any convenientlength but is preferably long enough to extend the positioning handle292 to a point sufficiently beyond the incision that manipulation of theposition of the contact members 1 does not interfere with the surgeon'sability to visualize the surgical site. Thus, each cable 287 has adistal portion affixed to the, ball joint 280, and a proximal portionaffixed to a positioning handle 292 having the cables attached thereto.In one configuration, the plurality of positioning cables 287 areaffixed about a plurality of attachment points 293, respectively, on thepositioning handle 292.

[0198] In the embodiment of FIGS. 54B and 54C, the positioning handle292 has a recessed area 295 in the bottom surface and a post 294disposed in the recessed area 295 about which the cables 287 are affixedat several points. The most proximal portion of the positioning handle292 is adapted to be grasped by the hand and may be rotated about thepost 294 to provide selective tension on the cables 287, therebyrepositioning the contact members 1 at the distal end of the shaft means3.

[0199] As is apparent from the foregoing description, an importantfunction of a shaft means is to selectively place the contact members atthe appropriate site on the beating heart, while providing sufficientflexibility and positioning adjustability for different clinicalsituations and for different surgical access techniques. Also, the shaftis typically mounted or attached to a stable support at a proximal endand typically at a point outside the patient's chest. Thus, it isadvantageous to provide a shaft means having the ability to bepositioned in several configurations, particularly relative to a stablesupport such as a surgical retractor or access platform which is used toprovide access to the beating heart.

[0200] Referring to FIGS. 55A and 55B, because the available access andworking space for the surgeon may be limited, certain embodiments of theinvention may be contained substantially within the chest cavity.Preferably, such a stabilizing means is connected to the rib retractorand may be affixed to one or both sides of the opening created byspreading the ribs using the rib retractor.

[0201] Referring to FIG. 55A, rib retractor 296 is shown in an openposition whereby blades 297 engage and spread the ribs. A pair ofstabilizing bars 298 having a conventional ratchet means 299 attached atthe end thereof are positioned beneath the retractor. The ratchet means299 is comprised of a plurality of teeth 300 on the stabilizing bars 298and a ratcheting aperture 301 permitting one-way passage of thestabilizing bars 298 unless released by a release mechanism. Thestabilizing bars 298 are curved downward such that as the bars areadvanced through the ratchet means 299, the lowermost portion of thestabilizing bars 298 engages the beating heart 301 a proximate to theanastomosis site.

[0202] Referring to FIG. 55B, the orientation of the portion of thestabilizing means which engages the heart relative to the rib retractor296 is similar to the embodiment shown in FIG. 55A. In this embodiment,a contact member 1 is attached on opposite ends to at least twomalleable supports 302 which are in turn attached to the rib retractor296. The malleable supports 302 are preferably made of stainless steelbands which are woven in a mesh or have a repeating serpentineconfiguration to allow for substantial extension into the chest cavity.This configuration yields a malleable support 302 with sufficienttensile strength to maintain a stabilizing force at the anastomosis sitewhile allowing the surgeon to manipulate the malleable supports 302within the chest cavity to achieve the desired orientation relative tothe beating heart.

[0203] As noted above, at the upper end of the shaft means 3, the shaftmeans 3 may be attached to a fixed support which may be any surface orstructure which does not move with the beating heart. For example, theshaft means 3 may be attached to a fixture on the retractor system usedto spread the ribs for access to the heart or may be attached to a fixedstructure such as the surgical table or associated aperture which is notconnected to the patient. In a preferred embodiment, the shaft means 3is directly attached to a component of the retractor system which isdesigned to receive the shaft means 3 and to maintain the position andorientation of the shaft means 3 during the procedure.

[0204] Referring to FIGS. 56A and 56B, an adjustable slide mechanism isprovided to the shaft means 3 such that the shaft means can becontinuously positioned relative to a retractor. For example, in FIG.56A, a curved shaft 303 traverses a ball joint 304 disposed at the endof an adjustable arm 305 which connects the shaft means to the retractor306 and is lockable relative to the retractor 306. The curved shaft 303traverses the ball joint 304, as described previously, and is positionedby sliding the shaft 303 relative to the ball joint 304, providing theability for the contact members 1 to be positioned at any point within agiven arc as defined by the flexible shaft 303. Also, the entirety ofthe curved shaft 303 may be positioned in a perpendicular direction awayfrom the length of the retractor blade 307 using the adjustable arm 305.FIG. 56B shows a top view from A-A of the adjustable arm 305 which mayhave a slot or groove formed in the body thereof allowing continuouspositioning until the arm is fixed in position by a locking mechanism308. Thumbscrew 312 c locks the position of ball 304 in member in place.

[0205] In FIG. 56C, the shaft means 3 is comprised of a pair of parallelshafts 309 and 310 which slide around an axle 311 disposed in atightening mechanism 312 affixed to the retractor 313. The position ofthe shaft means 3 relative to the retractor 313 is adjustable by slidingthe shaft means 3 along the axle 311. Moving handle 311 a causes acorresponding motion in the contact members 1. Tightening thumbscrew 312c locks clamp members 312 a, 312 b onto port 312 d and shafts 309, 310simultaneously.

[0206] Referring to FIG. 57, an adjustable arm may be provided forcontinuously adjusting the distance between the retractor or otherstable support and the shaft means of the means for stabilizing thebeating heart of the invention. At one end of the adjustable arm, theshaft means 3 traverse a ball joint 314 which is contained in a socket315 formed in the body of the adjustable arm. The tightness of the balljoint 314 may be adjusted by tightening a shaft 316 affixed to thesocket 315 and which passes through the body 318 of the adjustable arm.The tightening shaft 316 which is in turn connected to a rotating knob319 that may tighten or loosen the ball joint 314 by tightening thesocket 315 via the tightening shaft 316. The distance between the shaftmeans 3 and the ball joint 314 is also adjustable relative to the stablesupport 320 by virtue of a slit or groove 321 formed in the body of theadjustable arm. A locking mechanism 322 is disposed within the groove321 such that actuating a locking handle 323 fixes the position of theadjustable arm by tightening the locking mechanism 322 about the groove321.

[0207]FIGS. 58A, 58B, and 58C are multiple segment shaft means 3 havingalternate configurations to permit adjustable positioning. FIG. 58A hasan elbow joint 324 with a hinge attaching upper dual shaft members 325a, 325 b, and lower dual shaft members 326 a, 326 b, such that the upperand lower shafts members are continuously positioned relative to aretractor or other stable support 327. The assembly may be attached tothe retractor and the lower dual blade shaft members 326 a, 326 b areattached to the contact members, by rotating joints 328 while the upperdual shaft members 325 a, 325 b are attached to the support by a secondrotating joint 329. FIG. 58B has two shafts which are positioned toextend in a horizontal plane by extending from beneath a retractor blade330 and by rotating around at least one circular joint 331 disposedbetween a first and second shaft 332 and 333. At the end of the secondshaft 333, the contact members 1 may be provided with a third verticalshaft 334 having a ball joint 335 disposed at a proximal end thereof andwhich is affixed to the second shaft member 333.

[0208] One particularly useful feature of the shaft means of theinvention is the ability to extend the distal end of the shaft in acontinuous or telescopic fashion such that the contact members can becontinuously positioned downwards relative to the proximal end of theshaft that is in turn attached to a retractor or other stable support.The degree of downward extension may be provided by several mechanicalembodiments. FIG. 58C is a telescoping shaft member 336 having a lowershaft 337 concentrically oriented within an upper shaft 338 and alocking means 339 for fixing the position of the lower shaft 337relative to the upper shaft 338. Additionally, the contact members 1 maybe positioned by pivot 339 located at the proximal distal ends of thelower shaft 337. The upper shaft 338 may also be positioned relative tothe retractor blade 330 by a tilting mechanism 340 that adjusts theangle of the upper shaft 338 relative to the retractor blade 330.

[0209] Referring to FIGS. 59A, 59B, and 59C, the stabilizing means ofthe invention may be provided by a plurality of adjustable attachmentsthat affix the proximal end of a shaft or shafts to a retractor. Forexample, in FIG. 59A, a plurality of telescoping shaft means 341 areaffixed to several pivoted joints 342 or hinges on a retractor blade 343such that the contact members 1 can be continually positioned in threedimensions relative to the retractor blade 343 which grips one edge ofan incision. When retracted, the contract members 1 are containedentirely within a recessed housing 343a formed in the retractor blade343.

[0210] In the embodiment of FIG. 59B, a lockable rotatable arm 344 isprovided that may be locked or unlocked to be positioned vertically by afirst hinge 345 and to swing or rotate around a second binge 346 whereinboth hinges are mounted in a retractor arm or a retractor blade 343.

[0211] In FIG. 59C, the shaft means has an adjusting knob 347 affixed tothe proximal end of a telescoping shaft means 348 at a point along theretractor arm 349 or the retractor blade 343. By loosening the adjustingknob 347, the telescoping shaft means 348 may be extended or retractedrelative to the retractor arm 349 and the retractor blade 343 therebyallowing the contact members 1 to swing into position to be brought intocontact with the beating heart.

[0212] In the embodiment of FIG. 60, a flexible central shaft 350 havinga handle 351 at the most proximal end is disposed within at least oneshaft guide 352, and preferably a series of shaft guides 352, 353, and354. The handle 351 is adapted to be held by the hand and allows bothrotation of the flexible central shaft 350 and positioning of thecontact members 1 by extension or retraction of the handle 351. Any ofthe series of shaft guides 352, 353, and 354 may be straight or formedto have a predetermined curve to alter the direction of the centralshaft 350. A proximal shaft guide 354 may be integral with a retractor355 used to open a surgical incision. A particularly preferred lowprofile embodiment of FIG. 60 has a shaft guide 354 integrallyassociated with a cross-member 356 that connects the arms of retractorblades 357. The shaft means 3 at the distal end of the central shaft 350may be straight or curved and rigid or flexible as desired. To fix theposition of the central shaft 350, a lock mechanism 358 is provided,preferably at a proximal portion of the central shaft 350, to fix theposition of the central shaft relative to the shaft guides 352, 353, and354.

[0213] Referring to FIG. 61, as noted above, attachment to a ribretractor is a preferred technique for fixing the position andorientation of the stabilizing means. The stabilizing means of theinvention may therefore advantageously attached to a fixture attached toa rib retractor 359 or may be configured to be directly incorporatedinto the body of a portion of the rib retractor 359. A surgical ribretractor 359 is generally comprised of a body 360 having blades 361attached thereto, which engage the ribs and spread the ribs when theretractor 359 is operated to move the blades 361 apart from one another.The space created by the retracted blades 361 provides access to theheart. Thus, once the retractor 359 is locked into the open position,the stabilizing means may be applied to the heart and a stabilizingforce maintained at the site of the anastomosis by fixing the positionand orientation of the shaft means 3 relative to the rib retractor 359.Referring again to FIG. 61, the shaft means 3 may traverse the width ofthe body 360 of the retractor 359 and is held in place by an upper plate362 and a lower plate 363 having circular openings 364 therein throughwhich the shaft means 3 passes and which maintain the position of asphere 365 positioned between the upper plate 362 and lower plate 363.The size of the openings 364 is larger than the diameter of the shaftmeans 3 but smaller than the largest diameter of the sphere 365. Thus,the shaft means 3 passes through the sphere 365 and may pivot about apoint approximately at the center of the sphere 365.

[0214] Referring to FIG. 62, the stabilizing means of the invention maybe provided by a shaft means 3 that extends from a cross-arm 366connecting the individual arms 367 of a surgical retractor such that theshaft means 3 extends between the arms 367 attached to the retractorblades 368 and below the level of the retractor blades 368 such that thecontact members 1 and separate shaft 369 is positioned beneath the levelof the retractor blades 368 and is generally contained within the chestcavity. This embodiment is a low profile design wherein a portion of theshaft means 3 extends into the chest cavity and has a secondsubstantially horizontal shaft 369 extending from the distal end 370thereof.

[0215] Referring to FIG. 63, the stabilizing means of the invention mayadvantageously be provided with a rib locking mechanism 371 affixed toeither side of a rib 372 to form a stable support for shaft means 3 thatextends from the rib locking mechanism 371 into the chest cavity. Therib locking mechanism 371 is comprised of an adjustable post 373preferably disposed within a slot 376 formed in the body of the riblocking mechanism 371 and is positioned between two adjacent ribs 372,373 and a blade 374 affixed to the opposite side of the rib 372 mostadjacent to the incision. The position of the blade 374 is adjustablerelative to the post 373 by sliding the mechanism 371 along the slot 376and fixing it in place with a locking latch 373.

[0216] As noted herein, the embodiments of the stabilizing means of theinvention may also be used to position the heart to facilitateperforming the bypass surgery or any other cardiac procedure where theposition of the beating heart may be adjusted. Referring to FIG. 64, theembodiment of FIG. 63 may be utilized as a heart positioning devicerequiring only the modification that the shaft means 3 affixed to anidentical or equivalent rib locking mechanism 371 and the contactmembers 1 have a length and tensile strength such that the contactmembers 1 can maintained in a position about the periphery of thebeating heart as desired.

[0217] In combination with the several designs for contact members andrelated features described previously herein, the configuration andconstruction of the element which is attached to the contact membersprincipally the shaft means, may partially comprise the contact membersand may be provided in several alternative designs without departingfrom the spirit of the invention. As indicated previously, certainvariations may depend on the surgical demands of a particular procedure,and will depend on the nature of the surgical incision(s) used to accessthe beating heart. For example, some embodiments of the invention areparticularly useful where a minimally invasive incision is created, andthe procedure is performed by introducing instruments through a cannulaor a hollow shaft that provides access to the heart. FIGS. 65A through65D show an embodiment of the invention whereby a means for stabilizingthe beating heart is provided that is integral or closely associatedwith a hollow shaft 386 that defines a surgical field around the site ofthe anastomosis. In FIG. 65A a hollow shaft 386 is provided having alower cylindrical portion 387 that splits into two semi-cylindricalportions 388 a and 388 b that define the surgical field for ananastomosis of a target vessel 389.

[0218] Preferably, the bottom surface 390 has an opening 391 throughwhich the vessel 389 passes such that the vessel lies within the opening391 and within the larger space created by splitting of the hollow shaft386 to create the surgical field. In this embodiment, instruments may beintroduced either through the hollow shaft portion 386 of the device orthrough the split portion of the lower portion 387 of the shaft toprovide stabilization and access to the vessel 389. The opening actionof the lower portion 387 of the shaft may be provided by a rotatingshaft means 3 which, when rotated, forces the lower portion 387 to splitinto the semi-cylindrical portions 388 a and 388 b.

[0219] Referring to FIG. 65B, a unitary hollow shaft 392 may be providedthat contacts the beating heart about the bottom surface 390, to providethe stabilization function, and has a plurality of openings 393 disposedin the body 394 thereof. Preferably at least one passage 395 is providedin the bottom surface 390 such that the target vessel 389 may bedisposed within the passage 395. A second passage 396 may be provided inthe bottom surface 390 of the unitary hollow shaft 392, preferably at anopposite end, such that the vessel may pass through the openings 395,396, or where a single opening is provided (not shown) the edge of thebottom surface opposite the opening 395 acts as an occluder. Largeropenings 393 in the body of the unitary shaft 392 may be provided toenable the surgeon to have access to the target 389 vessel through thebody of the unitary shaft 392.

[0220]FIG. 65C is a hollow shaft element 398 having formed therein apair of contact members 1 of the type described previously, but whichfold out from the body 399 of the shaft by virtue of a hinge or pivot400 at the lower portion 401 of the shaft element 399. By folding outthe contact members 1, which are maintained substantially integral tothe shaft element during insertion of the shaft element 398 through asurgical incision, the contact members 1 engage the surface of thebeating heart and provide the stabilization function. The surgeon mayintroduce instruments through the hollow portion of the shaft element398, or from another direction to achieve the anastomosis.

[0221] Referring to FIG. 65D, the application of the stabilizing forceneed not be applied directly below the surgical field created by theshaft element 398. The embodiment of FIG. 65D has an annular ring 402formed in the bottom portion 391 of the shaft element 398 and that mayrotate about the axis provided by a rod 403 or the shaft means 3 passingthrough the wall of the shaft element 398, and which is affixed to theannular ring 402. By rotating the rod 403, the annular ring 402 rotatesout from under the bottom 391 of the shaft element 398, and may bepositioned to contact the surface of the beating heart in an annularfashion adjacent and tangent to the shaft element 398. As with otherembodiments described herein, the annular ring structure 402 thatapplies the stabilizing function may have at least one passage 464formed in the bottom surface such that the vessel 389 may be positionedtherein. The passage 464 may pass through the entirety of the ring 402making it a “C” or “V” shaped contact member (not shown), which willallow easy removal from the field after construction of the anastomosisfastening the graft to the heart. Alternatively, the ring structure 402may be cut or broken for removal if necessary.

[0222] Referring to FIG. 66, this embodiment of the stabilizing means iscomprised of an elongated sheath member 405 which wraps around the heartin a strap-like fashion to restrict the motion of the heart. Thisembodiment may be used with a thoracotomy providing surgical access, butis particularly useful when access to the beating heart is provided by asternotomy. The sheath member 405 is positioned to surround the heartand manipulated so that each end of the sheath member 405 extends out ofthe chest cavity through the sternotomy. If desired, at least one end ofeach sheath member 405 is attached to a retractor 406 to secure theposition of the sheath member 405. The sheath member 405 may have aplurality of support attachments 407 which engage the exterior of theheart to hold it in place. At the point where the support attachments407 contact the surface of the heart, the support attachments 407 mayhave friction means 4 (not shown) attached to the surface which is indirect contact with the heart. The support attachments 407 may have orbe comprised of fluid-filled members 408 which cushion the heart againstthe sheath member 405, and absorb the motion of the heart while it isstabilized. Where the sheath member 405 has one or more fluid-filledmembers 408, the sheath member 405 may also include at least one lumen409 for introduction of air or a biocompatible fluid to the inflatablemembers 408, which may be inflated separately or simultaneously. In theformer instance, a separate lumen 409 is provided for each inflatablemember 408. The insertion of the sheath member 405 into the chest cavitymay be performed while the inflatable members 408 are deflated and isachieved manually or by a conventional guide and/or guide wire. Each ofthe support attachments 407 may be permanently attached to the sheathmember 405 or may slide along the length of the sheath member 405.Alternatively, alone or in combination with other inflatable members,the inflatable member 408 is positioned immediately proximate to thetarget coronary artery to achieve a more localized stabilization. Thus,the inflatable members of the invention may lie next to, or maysurround, the heart of the target coronary artery and may have openingsor apertures placed in the body thereof through which surgicalprocedures are performed. An additional stabilizing force may be appliedwhen the inflatable member 408 fills the space between the heart and theenclosing structure, such as the pericardial ling or the back of theribs. When the inflatable member 408 is appropriately inflated, thetarget artery site may be pressed against a proximate stabilizingstructure, such as contact member 1, the back of edge of the surgicalincision. The fluid-filled or inflatable cushioning, stabilizing, orpositioning means could also be applied via a rigid, malleable,deformable, or removable shaft, handle, mounting, or inflation means.

[0223] Similarly, referring to FIG. 67, a strap 410 may be providedwhich is arranged to pass over opposite retractor blades 411, to passunderneath the heart, and which may be mounted at both ends to a crank412 for selective movement of the strap 411. By turning the crank 412,or by otherwise manipulating the position of the strap 411, the heartmay be rotated for selective positioning or to provide access to variousregions of the heart. The cranks 412 are advantageously attached to theretractor used to maintain spreading of the ribs in a minimally invasivethoracotomy.

[0224] As noted above, in addition to stabilization of the beatingheart, the devices and methods of the invention may be used as shown inFIGS. 66 and 67 to selectively position the heart. Additionally, analternate to a continuous strap 410 is shown in FIGS. 68A, 68B, and 68Cand is comprised of a substantially flat, flexible sheet 413 positionedunder the heart. One side of the sheet 413 may have a hydrogel 414coating, or a coating of a similar material that adheres to theepicardial surface. Preferably, the other side of the sheet 413 issmooth. In a preferred embodiment, two sheets 413 are joined at theirrespective edges to form an interstitial space (not shown) therebetween.Perfusion of the interstitial space with fluid softens the hydrogel 414,allowing ready repositioning or removal of the sheets 413.

[0225] Depending on the nature of the surgical procedure, it may bedesirable to lock the contact members 1 in place by manipulating theirposition from a location remote from the surgical field. In theembodiment of FIG. 69, a plurality of telescoping shafts 415 areprovided which engage a contact member 1 at their most distal end.Preferably, each telescopic shaft 415 is affixed to a point on theretractor blade 416, thereby allowing the telescopic shafts 258 to becollectively adjustable to position the contact members at any pointwithin the range of movement of the telescoping shafts 415 within thesurgical field. At the most proximal point of each telescopic shaft 415,the shaft is affixed to the retractor blade 416 by virtue of a hydraulicactuator 417 that fixes the orientation of each telescopic shaft 415relative to the retractor blade 416. Each hydraulic actuator 417 isattached to a lock valve 418 via non-expanding hydraulic hoses 419.Typically, the lock valve comprises a reservoir 420 and a hand-activatedswitch 421 for closing the lock valve 418 to lock the hydraulicactuators 417 into position. Any number of telescopic shafts 415 may beprovided, however, it is preferable that a plurality of mounting pointsare available at various locations on the retractor blade 418 such thatthe surgeon can individually attach several, preferably at least three,telescopic shafts 415 to the retractor blades 416 at the locations bestsuited for each surgical procedure.

[0226] Referring to the embodiment of FIGS. 70A through 70D, astabilizing means is provided with a shaft means 3 comprised of aplurality of arms connected by joints having selectively placed frictionsurfaces associated therewith that freeze the joints and adjustable armsinto a set configuration when the contact members are displaced upwardsby the motion of the beating heart. Referring to FIG. 70B, the retractorblade 416 has a locking mechanism 422 with an internal cam shaft 422 aactuated by a handle 422 b that expands a first curved leaf spring 422 cto fix the position of a first shaft 424 relative to the retractor blade416. As shown in FIG. 70A, the first shaft 424 is attached to a firstfriction joint 425 permitting rotation of the joint about an axisperpendicular to first shaft 424. Referring to FIG. 70C, the frictionjoint 425 is comprised of a lower housing 426 affixed to the first shaft424 and an upper housing 427 affixed to a second shaft 428 which may bea discrete cylindrical shaft as the first or may be an extension of thehousing of the friction joint 425. A ball pivot 429 is positionedbetween the upper 427 and lower housing 426 to allow the individualhousings to rotate about each other. Either the upper 427 or lower 426housing has disposed therein a friction surface 430, and the oppositehousing has a friction engaging means such as teeth 431. When eitherhousing is displaced by tilting about the ball pivot 429, the frictionsurface 430 contacts the friction engaging means 431 and freezes theposition of the friction joint 425. The second shaft may be connected toa second friction joint 432 having an equivalent construction to thefirst.

[0227] Referring to FIGS. 70A and 70D, a rotatable shaft means 433 iscomprised of a central rod 434 disposed within a housing 438 having aratcheting mechanism formed from tongues 435 engaging teeth around saidcentral rod 434 to fix the rotatable position of the rotatable shaftmeans 433. The rotatable shaft means 433 is connected to the contactmembers 1, for example, by a hinge 436-having a shaft 439 resistant torotation by teeth (not shown) engaged by molded tongues 437.

[0228] In the embodiment of FIGS. 71A through 71D, a retractor blade 440is adapted to receive a clip into which is inserted a flexible slidehaving a contractible shaft means at the distal end thereof and meansfor extending the contractible shaft. Referring first to FIG. 71C, theassembly includes a C-shaped clip 441 for attaching the stabilizingmeans to the retractor blade 440. The clip has at least one lip 442adapted to fit within a guide 443 formed in the retractor blade 440. Thebody of the clip 441 also has a slot 444 around the outside of thecurved portion as shown in FIGS. 71A and 71B and in phantom in FIG. 71Cfor insertion of a flexible slide 445. FIG. 71D shows the flexible slide445 that fits inside the slot 444 formed in the clip 441 such that theflexible slide enters the clip 441 through the slot 444 and curvesaround to conform to the shape of the clip 441. A block 440 is mountedat the distal end of the flexible slide 445.

[0229] An extendable shaft means 447 is attached to the block 446 andhas an unexpandable hydraulic tube 448 affixed thereto which is in fluidconnection with a syringe 449 or other such fluid containing apparatusto apply hydraulic pressure through the tube 448 to extend the shaftmeans 447. Preferably, the syringe has a one-way valve 450 with arelease valve 451 such that hydraulic fluid pressure is applied toprogressively advance the extendable shaft means 447, while the one-wayvalve 450 prevents the extendable shaft means 447 from contracting. Uponcompletion of the procedure, the hydraulic pressure is released byactivating release valve 451.

[0230] Referring to FIG. 71A, the surgeon would first insert the clip441 onto the retractor blade 440 by inserting the flexible slide 445into the slot 444. The flexible slide 445 is thereby advanced from thetop of the clip 441 through to the bottom until the extendable shaftmeans 447 is in position to be extended to bring the contact members 1into conforming engagement with the heart. With one hand, i.e., via thesyringe 449, fluid is injected into the extendable shaft 447 to causethe contact members 1 to engage the heart. Note also that the guide 443in the retractor blade 440 may extend the length of the blade 445,allowing selective positioning of the clip 441 along the blade 440.

[0231] Referring to FIG. 72, the means for stabilizing the beating heartof the invention is shown in use together with a rib retractor 452 andadditional apparatus 453, 454 which may be used during the beating heartCABG procedure. In use, the blades 455 of the retractor separate theribs, thereby providing an access space for the introduction of surgicalinstruments, including the stabilizing means of the invention. Thestabilizing means is thus brought into contact with the heart such thatthe contact members 1 are proximate to the target artery 456. Astabilizing force is exerted in an amount sufficient to minimize themotion of the beating heart, including fixing the stabilizing means inplace, preferably by attachment to the rib retractor 452.

[0232] Referring to FIG. 73, the stabilizing means is comprised of apair of rectangular, substantially planar contact members 1, which areplaced proximate to a target artery 456. The shaft means 3 isconformable such that it may be conveniently attached to the ribretractor 452. As shown in FIG. 73, the surgeon may readily adjust theorientation and positioning of the connecting shaft 2 and the contactmembers 1 relative to the shaft means 3 while the stabilizing means isin continuous contact with the heart by manipulating the thumbscrew 457at the proximal end of the instrument. FIG. 74 shows a later stage ofthe procedure at a point where the anastomosis is being completed bysuturing at target artery 456. The stabilizing means thus maintains astabilizing force at the anastomosis site for the duration of theprocedure.

[0233] As described above in several embodiments of the invention, thestabilizing means may advantageously be integrated with a relatedsurgical device such as a retractor that is used to spread the ribs inpreparation for the cardiac surgery.. FIG. 75 is an embodiment of theinvention having a pair of shaft means 3 integrated with the arms of aretractor 459 suitable for spreading the ribs in a minimally invasivecardiac surgery. The stabilizing means are comprised of shafts havingadjustable links 459 as previously described that provide forpositioning of the contact members 1. The shaft means 3 also traverseball joints 460 that are directly affixed to the arm 458 of theretractor blade, and terminate with adjustable handles 460 for lockingthe position of the shaft means 3 and contact members 1 in place.

[0234] Referring to FIG. 76, a further embodiment of the means forstabilizing the beating heart of the invention is illustrated solidlyattached to an arm 463 of a rib retractor 464 via a quick-locking basemeans which allows exceptional maneuverability in the orientation andplacement of the contact member 1. In addition, auxiliary surgicalinstruments 465 consisting of, for example, a grasper, positioner,light, blower, suction device, etc., may be attached to a second arm 466of the retractor via, for example, a deformable wire 465′ anddovetail/clamping means similar to means 470, 474 described below. Thisallows for interchanging the positions of the stabilizing means and theauxiliary surgical instruments as desired. In accordance with theinvention, the stabilizing means is comprised of several closelycooperating parts, which includes a quick-locking base/shaft lockmechanism 467, an elongate shaft means 3, a quick-locking handlemechanism 468 and a heart contact member 1. The stabilizing means andmeans for mounting the stabilizing means to the retractor arm via inpart the base/shaft lock mechanism 467, provide a combination in whichthe shaft means 3 of the stabilizing means can be quickly rotated-andtranslated along several degrees of freedom. Once the contact member 1is correctly positioned to exert the stabilizing force on the heartdesired by a surgeon, the stabilizing means may be quickly and solidlylocked to the retractor arm 463 and the contact member 1 is also solidlylocked in position against the heart. The stabilizing means is just asquickly and easily removed from its position after surgery. Thus thecombination of the invention depicted generally in the FIG. 76 providesan extremely solid heart stabilizing means which has the addedadvantages of-very quick locking and unlocking mechanisms, wherein theshaft means and stabilizing means in general are locked in position byrespective locking mechanisms such as, for example, screw means, camlever means, etc. In addition, the stabilizing means and base mechanismconfiguration may be sturdily manufactured from plastic rather thanmetal materials, thus facilitating the manufacturing process. Also, thebase/shaft lock mechanism 467 always reman out of a surgeon'sway, at themargin of the surgical field while still allowing the contact member 1to be positioned at any position and at any angle within the entiresurgical field.

[0235] It is to be understood that the stabilizing means of the presentinvention may be solidly secured to a platform other than the retractor464 such as, for example, a rail structure on the surgical table (notshown), a cannula secured between adjacent ribs as disclosed in FIGS.13A-13E, 14, etc. Thus the quick-locking and readily maneuverableconfigurations of the present invention readily are adaptable to suchalternative supporting platforms which would replace the retractor. Inaddition, the mounting configuration of the embodiments of FIGS. 76-81may be used with other stabilizing means embodiments of previousdescription hereinabove.

[0236] Referring to FIG. 77, the base/shaft lock mechanism 467 is shownin exploded view thereby further illustrating the base means by whichthe stabilizing means is attached to the retractor arm 463. In thisspecific example, the retractor arm 463 (as well as the arm 466 of FIG.76) is modified to include a base-supporting pedestal, hereinexemplified by a generally rectangular male dovetail member 470 formedin the upper surface thereof. A locking notch 471 is formed in thepedestal (hereinafter referred to more particularly as the dovetailmember 470) and provides means for locking a base 472 (FIG. 76) forholding the auxiliary surgical instruments of previous mention such asthe grasper 465 of FIG. 76. The notch 471 is not necessary and is notused in attaching the base/shaft lock mechanism 467 of the stabilizermeans to the dovetail member 470, as is described below.

[0237] Referring in addition to FIGS. 78, 79, 80 and 81 as well as FIG.77, the base/shaft. lock mechanism 467 includes a base 473 with aclamping means, herein exemplified by a generally rectangular femaledovetail 474 which matches the size and configuration of the dovetailmember 470 to allow the base 473 to be slid over the matching dovetailmember. The base 473 is formed with a central opening 477 therethrough(FIG. 81) thus providing a “Stationary” and a “moveable” wall 475, 476,respectively. It is to be understood that the term “wall” is used forpurposes of description simplification. Functionally, the walls comprise“contact areas” which provide specific points or small areas of contactand thus pressure points with respective pedestals to enhance thesolidity of the mounting mechanisms, as further described with referenceto FIGS. 78, 78A, 79, 81. A back wall 478 (FIG. 79) extends to thebottom of the base 473 and acts as a mechanical stop when installing thebase 473 on the dovetail member 470. The “moveable” wall 476 isselectively detached in part from the base g so as to pivot slightlyabout a generally horizontal axis 486 formed by a recess in the wall(FIG. 81), whereby the lower portion of the moveable wall 476 is allowedto move towards and away from the stationary wall 475. In use, theclamping means (hereinafter referred to more particularly as thedovetail 474) of the base is slid over the matching dovetail member 470on the retractor arm until the back wall 478 meets the respective edgeof the dovetail member 470, thereby providing a solid mechanical stopfor the base.. A clamp lever 479 having a general U shape and formed ofa spring material, includes inwardly bent ends 480 which act as a pivotaxis for the lever. The walls 475, 476 include respective ramps 481,with respective locking notches 482 integrally formed in the walls(FIGS. 79, 81). The locking notches 482 include respective stops formedalong their lower curvatures to prevent further downward movement of theclamp lever 479. The pivot ends 480 of the clamp lever 479, which isspring loaded inwardly, are inserted into coaxial holes 483 at the rearof the walls of the base 473. After the base is in place on the dovetailmember 470, the clamp lever 479 is pivoted downward, whereby the sidesof the lever bear against the ramps 481 to produce a graduallyincreasing force which drives the moveable wall 476 towards thestationary wall 475. The clamp lever is locked in place once it snapsinto the locking notches 482 in the ramps 481. This action clamps thedovetail 474 of the base solidly on the dovetail member 470, as moreclearly shown in FIG. 81, and as further described below. Other meansmay be used to provide the clamping action which locks the base to thepedestal. For example, the clamp lever 479 may be replaced by a cam andlever on one wall with a rod attached between the cam and the oppositewall such that rotation of the cam via the lever draws the wallstogether to clamp them onto the pedestal.

[0238] The dovetail member 470 is formed on both of the retractor arms463 and 466 and each includes the notch 471. As previously mentioned,the notch 471 is not necessary for attaching the stabilizing means toeither of the retractor arms since this embodiment of the inventionemploys the female dovetail 474 in the base 473 to provide a quick andsolid locked condition. However, auxiliary surgical instruments ordevices, which do not have the base 473 configuration, may be securelyattached to the dovetail member 470 of either retractor arm utilizing aslide-on solid female dovetail 469 formed in the base 472. See FIG. 76.A snap clip 487 is formed in the base 472 and includes a protrudingtooth adapted to snap into the notch 471 when the base reaches fullseating on the dovetail member 470 to lock the base in place. The base472 is quickly removed by lifting the clip 487 to disengage the toothfrom the notch 471, whereupon the base is slid off the dovetail member470. In FIG. 76, the deformable wire 465 may be used to support variousauxiliary surgical instruments such as those of previous mention in anydesired position and angle within the surgical field.

[0239] Referring to FIG. 81, the confronting “horizontal” seatingsurfaces of the walls 475, 476 are formed at precise angles relative tothe “horizontal” seating surfaces of the dovetail member 470, such thatonly outermost portions 484, 485 of the horizontal seating surfaces ofthe base 473 and dovetail member 470, respectively, actually makecontact with each other. This provides, for example, four widespread andthus solid areas of seating contact between the base 473 and theretractor arm 463, and thus a very solid base for supporting thestabilizing means. Furthermore, installation of the solid base isachieved very quickly with a simple pivoting downward of the clamp lever479 until it snaps into locked position in the locking notches 482. Arecess 560 in the dovetail 474 (FIG. 79) mates with a bump 561 in thedovetail member 470 (FIG. 78) to prevent the base from backing out fromthe member 470 after being locked.

[0240] In addition, specific points or areas of contact between theslanted sides of the male dovetail member 470 and of the female dovetail474 provide corresponding specific points or areas where pressure isapplied by the clamping means, that is, the female dovetail 474, againstthe male dovetail member 470. To this end, referring to FIG. 78A, arelief 562 in the slanted side of the dovetail member 470, provides apair of spaced-apart contact areas 563 on the respective side, whichareas 563 engage the confronting slanted side of the stationary wall475, slightly raised contact area 564 (FIG. 79), which is beneath theramp 481 in the moveable wall 476, provides a single pressure pointagainst the opposite slanted side of the dovetail member 470. Thus, thecombination of the opposing pair of pressure areas 563 and the singlepressure area 564 provide a “3 point” contact between the femaledovetail 474 and the male dovetail member 470. This prevents any rockingmotion, which contributes to the solidity of the base means mounting.

[0241] The base 473 is provided with a circular pedestal (hereinafterreferred to as a male dovetail member 489) for attaching a shaft-lockingsupport 490 FIG. 77) of the base/shaft lock mechanism 467 of theinvention to the base 473. However, before proceeding further, it is tobe understood that the invention combination contemplates an embodimentwherein the detachable base 473 as described above may be replaced by asolid mounting means integrally formed on, for example, the retractorarm 463 or 466 or suitably secured to the railing of a surgical table orother platform. To this end, an upper portion of the base 473, namelythe circular dovetail member 489 and the seating surfaces which supportthe member 489 and confront the bottom of the shaft-locking support 490,may be formed on a retractor arm or other suitable platform. Theshaft-locking support 490 then may be rotatably and detachably securedto the circular dovetail member 489, as further described below. Thus,it is not intended that the detachable base 473 be the sole means forsupporting the stabilizing means of the invention.

[0242] In addition, although the base 473 includes the clamping means,and the solid pedestal, that is, dovetail member 470, is formed on theretractor arm 463 or 466 or other suitable platform, the positions ofthe complementary clamping and pedestal means may be reversed. That is,the bottom of the base 473 may include a pedestal or male dovetailmember while the clamping means for locking onto the pedestal may beformed on the retractor arm or other platform.

[0243] The basic combination of the shaft-locking support 490 isillustrated in FIG. 77 and includes an inner housing 491 and acomplementary outer housing 492 adapted at their bottoms with a clampingmeans (hereinafter referred to as a female dovetail 493) whose diameterand configuration match those of the circular pedestal or dovetailmember 489 of the base 473. Referring also to FIGS. 82 and 83, thehousings 491, 492 are provided with a coaxial central bore adapted toreceive therethrough a cylindrical portion 494 of a shaft grip 495 inthe inner housing 491, and a combined screw 496 and knob 497 in theouter housing 492. The screw 496 is adapted to threadably engagematching threads in the cylindrical portion 494 of the shaft grip 495,to secure the two housings together, and when tightened tosimultaneously solidly lock the shaft-locking support 490 in position onthe base 473 by means of the circular dovetail 493 and circular dovetailmember 489. A shaft lock 498 is disposed within the shaft grip 495 andis adapted to apply a frictional surface against the shaft means 3 ofthe stabilizing means when the knob 497/screw 496 are tightened to theshaft grip 495. The same tightening procedure simultaneously forces thehousings 491, 492 towards each other to thereby lock the housingdovetail 493 to the circular dovetail member 489.

[0244] A compression spring 499 and a friction knob 500 may be coaxiallydisposed within a bore in the shaft grip 495 and combine to providesufficient constant frictional contact against the outer surface of theshaft means 3 to hold the shaft means in place within a shaft-enclosingmember 488 of the grip 495 when the knob 497/screw 496 are not tightenedsuch as when a surgeon is making adjustments to the stabilizing means. Aselected number of annular stabilizer locking disks 501 are coaxiallydisposed about the cylindrical portion 494 of the shaft grip 495 andwithin the inner housing 491, and act as a friction clutch mechanism toprevent horizontal rotation of the shaft means when the knob 497/screw496 is tightened to lock the stabilizing means. The details of thelocking action and mechanisms therefor are further described relative toFIGS. 82, 83.

[0245] As mentioned, the shaft means 3 is confined in theshaft-enclosing member 488 of the shaft grip 495 as further depicted inFIGS. 82 and 83, in frictional contact with the shaft lock 498 andfriction knob 500, whereby the shaft means 3 may be rotated about avertical third coaxial axis as well as translated up and down relativeto the shaft grip 495. In addition, the shaft means 3 and shaft grip 495may be rotated as a unit in a generally horizontal second axis whereinthe third axis is perpendicular to the second axis. Still further, theshaft means 3, shaft grip 495 and support 490 may be rotated, that is,swiveled as a unit about a generally vertical first axis. Thus, thecombination of the base/shaft lock mechanism 467 and shaft means 3 ofthe present invention allows four simultaneous directions of freedom ofmovement to facilitate the orientation of the distal end of the shaftmeans 3, and particularly the contact member 1, relative to thepatient's heart. Equally important, the present invention provides meanswithin the base/shaft lock mechanism 467 for quickly locking themechanism 467 and shaft means 3 in the selected orientation simply bytightening the single knob 497, as described in FIGS. 82, 83.

[0246] The shaft, means 3 is provided at its distal end with an improvedembodiment of the contact member 1, adapted for movement in all threedimensions to allow it flexibility in contacting a patient's heart. Theproximal end of the shaft means 3 is provided with the handle mechanism468 of previous mention in FIGS. 76, 77, which includes an angled handle503 rotatably secured to the proximal end of the shaft means, and a knob504 for locking the handle 503 and contact member 1 to the shaft means3, as further described in the FIGS. 87-91. In general, a partialrotation of the knob 504 causes a slight translation of a pushrod 505within the shaft means which, in turn, solidly locks the contact member1 in the orientation selected by the surgeon, as further describedbelow.

[0247] Referring now to FIGS. 82, 82A and 82B, the base 473 and theshaft-locking support 490 are illustrated in further detail, with thecircular dovetail member 489 in register with and locked to the femaledovetail 493 of the confronting inner and outer housings 491, 492. Thelocking action is provided by forming a pivot point 508, as by means ofan integral boss, along an arcuate portion at the top of the inner andouter housings 491, 492 where they meet when assembled. Note forexample, the gaps 509 FIG. 83) between the confronting edges of thehousings at either sides thereof which allow the housings to pivot aboutpoint 508 when forced together. Subsequent tightening of the screw 496forces the bottoms of the housings together as they pivot about thepivot point 508, to thus clamp the female dovetail 493 about thedovetail member 489 simultaneously with the locking of the shaft means 3via the shaft grip 495, the shaft lock 498 and stabilizer locking disks501. As may be seen in FIG. 82A, the slanted inner sides of the dovetail493 of both housings are provided with reliefs 493 thereby providingthree opposing contact areas 493, a&d three corresponding pressure areasagainst the circular dovetail member 489 to enhance locking stability.Further, as depicted in FIG. 82, solid seating of the dovetail 493 onthe dovetail member 489 is insured by forming the bottom, or“horizontal”, seating surface at a slight angle relative to theconfronting horizontal surface of the base 473 such that only anoutermost portion 507 makes contact along with the matching dovetails.See FIG. 82B. In addition, shallow reliefs are formed in the portions507 to provide three separate contact areas thereof which confront themating seating surfaces on the base 473, to further eliminate anypossibility of a rocking motion due to irregularities in the matingseating surfaces.

[0248] As previously noted, all similar components in, for example, theFIGS. 76-88, are similarly numbered to facilitate the descriptionprocess and provide continuity in the description of the equivalentcomponents throughout the specification.

[0249] Referring to FIGS. 82 and 83, the outer housing 492 includes agenerally semi-spherical outer wall, open at the bottom to include onehalf of the female dovetail 493, and inner axially-extending tabsarranged in a cylindrical configuration for facilitating alignment andinitial assembly of the housings 491, 492. One pair of diametricallyopposite alignment projections 510 (FIG. 82) define a bore 511therebetween which receives the end of the cylindrical portion 494 ofthe shaft grip 495. A second pair of projections comprise hooked clips512 (FIG. 83) spaced between the projections 510, which include radiallyinwardly extending hooks 513 adapted to slide over the end of thecylindrical portion 494 and snap down beyond an annular edge 514 thereof(FIG. 83). This loosely latches the housings 491 and 492 togetherthereby assembling the shaft-locking support 490 together on the base473 prior to securing it to the base. An annular lip 489 formed in theperiphery of the circular dovetail member 489 (best seen in FIG. 82) anda complementary annular recess in the confronting portions of thehousings 491, 492, loosely lock the shaft-locking support 490 to thebase 473 to prevent the support 490 from being dislodged from the basewhile adjustments to the stabilizing means are being made. The outerhousing 492 includes a screw bore 515 which rotatably supports the screw496. The knob 497 is securely attached to the screw 496 by suitablemeans such as press fitting, bonding, etc. The opposite end of the screwis provided with external threads adapted to engage internal threadsprovided in a coaxial bore in the cylindrical portion 494, as depictedat 516.

[0250] The inner housing 491 includes a generally cylindrical outer wallwith a radially inwardly extending annular wall 517 formed therein,thereby providing an annular surface 518 facing the shaft means 3. Thestabilizer locking disks 501 of previous mention, which herein includefour annular disks, are disposed against the surface 518 and areconfined in place by a confronting annular surface of the shaft lock498. A pair of alternate disks 501 a are keyed to the inner housing 491while the remaining pair of alternate disks 501 b are keyed to thecylindrical portion 494 of the shaft grip 495. Thus the locking frictionthat prevents rotation of the shaft means about the support means 490axis is increased due to the multiple friction surfaces. The oppositeend of the shaft grip 495 includes a passageway 519, formed by theshaft-enclosing member 488, within which is disposed the shaft means 3.The shaft lock 498 is provided with shaft-engaging portions havingV-shaped channels 520, FIG. 77 (or 532, FIG. 86) which firmly engage thecylindrical surface of the shaft means 3 when the screw 496 istightened. It follows that the shaft-enclosing member 488 of the shaftgrip 495 pulls the shaft means into the shaft lock channels 520 tomaximize the friction therebetween. When the screw 496 is not in thelocked condition, the spring 499 constantly urges the friction knob 500against the shaft means 3 to produce sufficient friction to maintain theshaft means in the orientation being set by a surgeon. Once the desiredorientation for the shaft means 3 is achieved, the shaft means 3 islocked in place and the shaft-locking support 490 simultaneously islocked to the base 473 by tightening the screw 496 via rotation of theknob 497.

[0251]FIGS. 84, 85 and 86 depict an alternative embodiment 490 a of theshaft-locking support 490 of FIGS. 77, 82 and 83, and particularly ofmechanism thereof which locks the shaft means 3 to the inner and outerhousings. Similar components are similarly numbered, while modified butequivalent components are similarly numbered and also include a letter“a”. In the alternative embodiment 490 a, the stabilizer locking disks501 and the friction knob 500 are dispensed with and in effect replacedby a modified shaft lock 498 a and a correspondingly modified innerhousing 491 a. To this end, the annular end of the inner housing 491 aterminates in a pair of concentric, annular ridges or teeth 526, whereinthe valleys of the teeth mesh with peaks of corresponding arcuateportions of teeth 528 formed in the confronting surface of the modifiedshaft lock 498 aThe arcuate length of the teeth 528 in the lock 498 amay be equal to the width of the lock, as readily seen in FIG. 86, ormay be formed as an annular disk with annular teeth which mesh with theannular teeth 526 in the housing 491 a. The shaft lock 498 a includes adepression 529 formed in the center thereof to allow some flexing inannular portions 566 of the shaft lock 498 aThis allows the teeth 528 atthe ends of the shaft lock 498 a to self-Align to the valleys of theteeth 526. When the lock is inserted into the shaft grip 495 a, acompression spring 530 may be inserted within the depression 529. Thespring 530 extends to an annular shoulder 531 formed in the confrontingend of a cylindrical portion 494 a of the shaft grip 495 a. A V-shapedgroove 532 is formed in either shaft-engaging portion of the shaft lock498 a, which grooves face the shaft means 3 within the shaft grip 495 a.At such time as the screw 496 is tightened to lock the stabilizingmeans, the shaft means 3 is pulled into high frictional contact with theV-shaped grooves 532 of the shaft lock 498 a by the shaft-enclosingmember 488 a of the shaft grip 495 a. Simultaneously, the teeth 528 ofthe lock are meshed firmly with the teeth 526 of the inner housing 491 aregardless of the angular position of the shaft means 3 relative to thegenerally horizontal second axis (corresponding to the axis of theshaft-locking support 490 a ). When the screw 496 is not tight, thespring 530 still applies a small force to the shaft lock 498 a whichapplies a small frictional force to maintain the orientation at whichthe shaft means 3 is set, while still allowing a surgeon to move theshaft means to any other desired orientation.

[0252] As an alternative to the shaft locks 498 and 498 a of FIGS. 82,83 and 84-86, respectively, the annular end of the inner housing 491 or491 amay be modified to define a shaft means 3 friction member which,when forced against the shaft means will act as a lock in place of theshaft locks 498 or 498 aThus, the shaft locks may be replaced by, forexample, a rubber, plastic, etc., annular ring or annular teeth (such asin FIGS. 84-86) against which the shaft means 3 is forced by tighteningof the screw means 496 to lock the shaft means 3.

[0253] Referring now to FIG. 87 and 88, the handle mechanism 468 of thestabilizing means, illustrated in FIGS. 76 and 77, is disclosed infurther detail. The mechanism 468 is rotatably secured to the proximalend of the shaft means 3 and is formed at a selected angle to the shaftmeans to permit a surgeon to swivel the mechanism to a preferredposition where the knob 504 is more readily accessible to allow quicklylocking the shaft means 3 in the orientation selected. In addition, theangled axis of the knob 504 relative to the shaft means 3 reduces thetendency of the shaft means 3 to rotate about its axis when a surgeonapplies torque to the knob 504 to lock the associated locking mechanism.The knob 504 is secured to a screw 539 by suitable means such as pressfitting, bonding, etc., whereby the combination knob/screw is similar tothe knob 497/screw 496 of previous mention in FIGS. 77, 82, 83. Rightand left handle covers 540, 541 comprise the handle 503 and provide thesupport for the handle mechanism. When assembled, the covers definegenerally a cylinder formed with the selected curvature. A secondaryinner molding, generally indicated at 542, includes various integrallyformed annular walls and shoulders for supporting and containing theknob 504/screw 539, as well as a go cooperating nut 543, an arcuatewedge 544, a shaft retaining ring 545, the proximal end of the shaftmeans 3, and a proximal end of the translatable pushrod 505. Theproximal end of the shaft means 3 includes an annular retaining ringslot 546 which secures the proximal end of the shaft means 3 withinsuitable annular walls in the corresponding end of the handle covers540, 541 when the retaining ring 545, confined by shoulders in the innermolding 542, is snapped into the slot 546 and the covers are assembled.The nut 543 is confined by shoulders in the inner molding 542, and thearcuate wedge 544 is slidably confined by correspondingly arcuate walls547 also formed in the inner molding.

[0254] As may be seen, rotation of the threaded screw 539 within theconfined threaded nut 543, causes translation of the screw, pivoting andthus translation of the translatable wedge 544 which abuts the screw,and translation of the pushrod 505 which abuts the translatable wedge.As is further described relative to FIGS. 89-91, any tightening orloosening of the screw 539, however slight, will cause a correspondingtranslation of the pushrod 505 into or out of the shaft means 3.

[0255] As depicted particularly in the FIGS. 76 and 77, the shaft means3 and thus the pushrod 505, are formed with a slight arcuateconfiguration, which permits additional degrees of freedom of movementand orientation of the distal end of the shaft means 3 and thus of theheart contact member 1, in accordance with the invention. Rotation ofthe shaft means 3 about the third axis of previous mention, within theshaft grip 495 or 495 a, moves the distal end of the shaft means 3through a circular path, while changing the angles through which thecontact member 1 can be oriented. This allows a surgeon to convenientlyachieve a wider range of positions and orientations of the contactmember relative to a patient's heart, while keeping the proximal end ofthe shaft means 3 and handle mechanism 468 out of the way as much aspossible.

[0256]FIGS. 89, 90 and 91 illustrate an associated mechanism formaneuverably supporting the improved embodiment of the contact member 1and for cooperatively assisting in the quick locking of the contactmember by a partial rotation of the knob 504 once the member ispositioned. To this end, the distal end of the shaft means 3 is providedwith exterior threads matching interior threads in a ball/socket 548.The distal end of the ball/socket 548 is provided with slots 549,whereby the remaining material comprises short extended tips 550 which,when bent in or inwardly formed, form a socket. A ball/post 551 includesa ball at one end and a post at the other. When the mechanism isassembled, the ball/post 551 is inserted into place within theball/socket 548 with the ball in the socket and the post protruding fromthe ball socket. A mechanism for providing a preloaded source, such as acompression spring 552, is coupled to the ball/socket 548 abutting theball. The spring 552 is urged by the distal end of the shaft means 3 toexert a preloaded or constant minimum force against the ball of theball/post 551. The post of the ballpost 551 is solidly fixed as by pressfitting, welding, etc., to the contact member 1. The distal end of thepushrod 505 passes through the spring 552 to abut the ball of theball/post 551. Thus when the screw 539 is not tightened, the distal endof the pushrod 505 exerts a slight pressure against the ball, howeverthe spring 552 maintains a preloaded force against the ball sufficientto maintain the contact member 1 at any orientation set by a surgeon.When the screw 539 is tightened, the pushrod 505 is forced against theball to prevent any further movement of the contact member 1. As may beseen, the contact member 1 can be tilted to assume many orientationssince the narrow center of the post can tilt into any of the four slotsin the ball/socket 552. In addition, simultaneous rotation of the curvedshaft means 3 provides a surgeon with even a greater variety oforientations of the contact member relative to a patient's heart.

[0257] The contact member 1 includes a preferred configuration whichimproves the size of the area of the heart which is visible to a surgeonwhile still providing the required suppression of heart movementnecessary to enable the efficient construction of the anastomosis. Moreparticularly, the pair of spaced-apart contact members 1 extend from acommon base portion 553, which uniquely first extends back away from thetips of the contact members at the point of attachment to the post, asshown at reference number 554. The spaced contact members 1 then curvedownward away from the common base portion 553 and back past the postand away from the shaft means 3. As may be seen in the FIGS. 76, 77,89-91, the contact member 1 of this embodiment uniquely is attached tothe post on the same surface as the surface that bears against thesurface of the beating heart. Since the members 1 separate at the baseportion 553 at a point 555 behind the distal end of the shaft means 3, asurgeon has an unobstructed and thus optimum view of the heart evenbelow the distal end of the shaft means 3. As described previouslyrelative to other contact members 1, the contact members 1 of FIGS.89-91 include friction means 556 selectively secured to the bottomsurfaces thereof to more securely engage a beating heart. In addition,the tips of the contact members are bent upward in the form of ski tips,to lessen their impact when the contact members are firmly pressedagainst a beating heart to suppress the anastomotic site.

[0258] Although screw means 496/497/516 and 539/504/543 are illustratedherein as a locking mechanism for the shaft-locking support 490 andhandle mechanism 468, respectively, it is to be understood that othermechanisms may be employed to fulfill the intent of the inventioncombination. For example, a cam/lever mechanism may be used to imparttranslation to a rod whose distal end is selectively coupled to asuitable flange or the like formed with the shaft lock 495 of theshaft-locking support 490. Such a cam/lever mechanism also may beattached to a rod which in turn imparts a pivoting movement ortranslation to a suitable bellcrank or pivotable member, which in turnimparts translation to the pushrod 505 of the shaft means 3. Thuslocking mechanisms other than those specifically described herein areintended within the scope of the embodiments of the invention.

[0259] As mentioned previously, it is the goal of the present inventionto provide an apparatus, or collection of apparatus, to facilitatecompleting a minimally invasive CABG procedure on the beating heart.Thus, each of the devices disclosed herein is preferably provided in anintegrated kit, having several individual instruments packaged thereinto provide the surgeon with each of the instruments necessary tocomplete the anastomosis on the beating heart. Since it is intended thatthe means for stabilizing the beating heart as described herein, will beintroduced directly into the thoracic cavity, and brought into directphysical contact with the beating heart, it is necessary that each ofthe devices disclosed herein be subjected to the sterilizationtechniques suitable for other surgical instruments. It is particularlypreferred that a substantial portion of the devices described herein beformed of a biocompatible and sterilizable plastic and maintained in asterile container completely enclosing the instrument whereby thecontainer provides a barrier against microorganisms and wherein thestabilizer means of the invention and the container in which theinstruments are packaged are sterilized. Sterilization of the containerand the instruments contained therein may be provided by conventionalsterilization methods such as ETO gas, high temperature and pressure, orgamma radiation. Preferably, the container is a sealable flexible bagthat may be sterilized either before or after having the instruments ofthe invention sealed therein.

[0260] The particular examples set forth herein are instructional andshould not be interpreted as limitations on the applications to whichthose of ordinary skill are able to apply this invention. Modificationsand other uses are available to those skilled in the art which areencompassed within the spirit and scope of the following claims.

1. A device for performing a surgical procedure on a beating heart, wherein a stable platform is provided, comprising: mounting means secured to the platform; shaft means having at a distal end a contact member for engaging the surface of the beating heart; and shaft support means having a moveable portion adapted to lock onto the mounting means while simultaneously locking thereto the shaft means, with the contact member in selective engagement with the beating heart.
 2. The device of claim 1 wherein the mounting means includes: first pedestal means affixed to the platform; and base means having the moveable portion adapted to lock onto the first pedestal means.
 3. The device of claim 2 wherein the base means includes: a generally hollow base wherein the moveable portion includes first clamping means engaging the first pedestal means; means for locking the first clamping means to said first pedestal means; and circular pedestal means formed in the base means.
 4. The device of claim 3 wherein the shaft support means includes: a pair of confronting housings adapted to have initial contact at upper points of contact; one of the housings having second clamping means contacting the circular pedestal means of the base means while allowing rotation of the shaft support means relative to the base means; and means supported within the housings for forcing the housings to pivot about the upper points of contact to lock the second clamping means to the circular pedestal means while simultaneously locking thereto the shaft means.
 5. The device of claim 4 wherein the shaft support means further includes: a stationary wall having a stationary complementing part of the second clamping means which matches the circular pedestal means; and said means for forcing the housings include screw means rotatably secured within said housings for forcing a moveable portion of the second clamping means towards the stationary part of the second clamping means to lock the shaft support means to the circular pedestal means.
 6. The device of claim 4 wherein: said first clamping means and said first pedestal means comprise matching female dovetail means and a male dovetail member, respectively; and said second clamping means and said circular pedestal means comprise matching female arcuate dovetail means and a male circular dovetail member, respectively.
 7. The device of claim 2 wherein: said first pedestal means comprises first dovetail means; said base means comprises; second dovetail means in the moveable portion thereof which matches the first dovetail means, and lever means for applying a force to the moveable portion to lock the second dovetail means to the first dovetail means; and said shaft support means comprises; confronting complementary housings having an arcuate dovetail means formed in the moveable portion thereof, screw means including a knob rotatably supported in one housing, shaft grip means rotatably supported in the other housing and having one end enclosing the shaft means and the other end threaded to engage the screw means, and friction means disposed between the shaft means and said other housing for applying light friction against the shaft means when the screw means is not tightened and for locking the shaft means and the shaft support means to the base means when the screw means is tightened.
 8. The device of claim 7 wherein: rotation of the screw means draws the -grip means- against the shaft means, forcing engagement of the friction means with said other housing, which forces the moveable arcuate dovetail means to lock to the base means to thereby lock the shaft means and the shaft support means from further movement.
 9. The device of claim 1 wherein the shaft support means includes: confronting housings having respective common areas at which initial contact is made when the housings are first forced together; one of the housings including a moveable arcuate clamping means for providing said lock to the mounting means; means for maneuverably gripping the shaft means; and means supported within the housings for forcing the housings together about said common areas to lock the shaft means to the gripping means while simultaneously locking the moveable arcuate clamping means to the mounting means.
 10. The device of claim 9 wherein the means for forcing includes: screw means supported within the housings and threadably engaging the gripping means; and wherein rotation of the screw means imparts translation of the gripping means relative to the shaft means to force the housings together about the mounting means.
 11. The device of claim 10 wherein: said mounting means includes circular pedestal means matching the moveable arcuate clamping means; and said gripping means includes an annular groove and said housings include associated hooked clips which snap into the annular groove to loosely assemble the shaft support means together while allowing orientation of the shaft means and of the contact member relative to the beating heart, prior to the locking process.
 12. The device of claim 10 wherein: the shaft support means is rotatable relative to the mounting means about a generally vertical first axis; the engaged screw means and gripping means are rotatable within the housings to allow corresponding rotation of the shaft means about a generally horizontal second axis; and the shaft means is rotatable within the gripping means about a third axis generally perpendicular to the second axis and is translatable relative to the gripping means.
 13. The device of claim 9 wherein the shaft support means further includes: friction means disposed between a first of the housings and the shaft means for preventing movement of the shaft means when the means for forcing is locked.
 14. The device of claim 13 wherein the friction means comprises: shaft locking means disposed against the shaft means; and a friction assembly disposed between the shaft locking means and the first housing.
 15. The device of claim 14 wherein the friction assembly includes: a housing friction disk keyed to the first housing; and a grip friction disk disposed against the housing friction disk and keyed to the gripping means.
 16. The device of claim 15 including: spring means disposed to consistently apply friction against the shaft means.
 17. The device of claim 14 wherein the friction assembly includes: annular teeth formed in a surface of the shaft locking means facing the first housing; and complementary annular teeth formed in a confronting surface of the first housing, wherein securing the means for forcing forces the confronting teeth to firmly mesh in wedge-surface frictional engagement.
 18. The device of claim 1 wherein the shaft means includes: ball and socket means coupling the contact member to the distal end of the shaft means; a pushrod translatably disposed in the shaft means with a distal end bearing against the ball; and handle means secured at an angle to a proximal end of the shaft means for imparting translation to the pushrod to lock the contact member in the selective engagement with the beating heart.
 19. The device of claim 1 wherein the shaft means further includes a mechanism for providing a preloaded force against said ball and socket means, said force sufficient to maintain said contact member in a selected orientation.
 20. The device of claim 19 wherein said mechanism comprises a compression spring.
 21. The device of claim 18 wherein the handle means includes: screw means rotatably secured in the proximal end of the handle; and a wedge moveably supported in the curved handle and abutting a proximal end of the pushrod; wherein rotation of the screw means imparts movement to the wedge and to the pushrod to lock the ball and socket means and thereby lock the contact member in said selective engagement.
 22. The device of claim 1 wherein the contact member is shaped in the configuration of a re-curve such that the surface thereof that engages the heart is the surface facing the distal end of the shaft means.
 23. The device of claim 22 wherein the contact member includes: a common base portion suitably affixed to the distal end of the shaft means; and a pair of spaced members extending from the common base portion in the re-curve configuration to engage the surface of the beating heart.
 24. The device of claim 1 wherein the shaft support means supports the shaft means on the mounting means while allowing several degrees of freedom of movement of the shaft means relative to the shaft support means and mounting means, prior to the locking procedures.
 25. The device of claim 24 wherein: the shaft support means is adapted for rotation relative to the mounting means about a generally vertical first axis; the shaft means is adapted for rotation relative to the shaft support means about a generally horizontal second axis; and the shaft means further is adapted for rotation about a third axis generally perpendicular to the second axis while being translatable along the third axis.
 26. A device for performing a surgical procedure on a beating heart, wherein a stable platform is provided, comprising: circular pedestal means selectively secured to the platform; shaft means including handle means at a proximal end thereof and a contact member at a distal end thereof, said handle means being adapted to lock the contact member in a selected orientation relative to the beating heart; and shaft support means supporting the shaft means in a selected orientation and having arcuate clamping means contacting the circular pedestal means, said arcuate clamping means being moveable to detachably lock the shaft support means to the circular pedestal means while the shaft means simultaneously is being locked to the shaft support means.
 27. A device for performing a surgical procedure on a beating heart, wherein a stable platform is provided, comprising: mounting means selectively secured to the platform; first adjusting means detachably secured to the mounting means; second adjusting means having at a distal end thereof a contact member for engagement with the beating heart; and said second adjusting means being supported by the first adjusting means for translation and rotation about several degrees of freedom of movement relative to the first adjusting means and the mounting means to enable selective engagement of the contact member with the beating heart.
 28. The device of claim 27 wherein: said first adjusting means is adapted for rotation relative to the mounting means about a generally vertical axis; said second adjusting means is adapted for rotation about a generally horizontal axis, as well as for translation and rotation relative to the first adjusting means about an axis perpendicular to the generally horizontal axis; and said contact member is tiltably secured to the distal end of the second adjusting means.
 29. The device of claim 27 further comprising: second mounting means selectively secured to the platform; auxiliary base means detachably secured to the second mounting means; and deformable support means secured at a proximal end thereof to the auxiliary base means for maneuverably supporting at a distal end thereof an auxiliary surgical instrument.
 30. A device for performing a surgical procedure on a beating heart, wherein a stable platform is provided, comprising: heart contacting means shaped to engage the surface of the beating heart to stabilize the heart; first adjusting means for maneuverably supporting and locking the heart contacting means in selective engagement with the beating heart surface; and second adjusting means for maneuverably supporting and locking the first adjusting means thereto, and including means for detachably securing the first adjusting means to the platform.
 31. The device of claim 30 wherein the first adjusting means comprises shaft means having distal and proximal ends, and including: ball/socket means tiltably securing the heart contacting means to the distal end of the shaft means; and a first mechanism integral with the proximal end of the shaft means for locking the heart contacting means in the selective engagement.
 32. The device of claim 30 wherein the means for detachably securing the second adjusting means includes: mounting means selectively secured to the platform and including circular pedestal means rotatably securing the first adjusting means thereto.
 33. The device of claim 32 wherein the second adjusting means comprises shaft support means including: means for gripping the first adjusting means; arcuate clamping means for detachably securing the shaft support means to the circular pedestal means of the mounting means; and a second mechanism for urging the arcuate clamping means into securing the shaft support means to the mounting means while simultaneously locking the first adjusting means via the gripping means.
 34. The device of claim 32 wherein the mounting means comprises: pedestal means selectively secured to the platform; and base means including, base clamping means for detachably securing the base means to the pedestal means, and a third mechanism for urging the base clamping means into locking the base means to the pedestal means.
 35. A method of stabilizing a patient's beating heart to enable performing a surgical procedure on the heart, comprising the steps of: providing a solid mounting means; detachably securing an adjusting means to the mounting means; maneuverably supporting a heart contacting member for selective adjustment thereof relative to the beating heart via the adjusting means; and engaging a surface of the beating heart to stabilize the beating heart at the site of the surgical procedure by the selective adjustment of the heart contacting member.
 36. The method of claim 35 wherein the step of engaging includes: rotating and translating the adjusting means through-several degrees of freedom of movement relative to the mounting means to provide selective orientation of the heart contacting member with respect to the beating heart.
 37. The method of claim 36 wherein the step of rotating and translating includes: rotating about a generally vertical first axis, about a generally horizontal second axis and about a third axis perpendicular to the second axis; and translating along the third axis.
 38. A stabilizing apparatus for enabling a surgical procedure on a beating heart, wherein a stable platform is provided, comprising: adjusting means selectively secured to the platform for effecting multiple degrees of freedom of movement with respect to the platform;. heart contacting means selectively secured to said adjusting means for engaging the surface of the beating heart in multiple degrees of freedom of movement with respect to the adjusting means; and said adjusting means including locking mechanisms for locking the adjusting means to the platform and the heart contacting means to the adjusting means.
 39. The stabilizing apparatus of claim 38 wherein the adjusting means includes: second adjusting means supporting the heart contacting means for effecting several degrees of freedom of movement with respect to the platform; and first adjusting means supporting the second adjusting means for effecting rotation of the first adjusting means with respect to the platform.
 40. The stabilizing apparatus of claim 38 wherein: said heart contacting means is tiltable through three degrees of freedom of movement; and said adjusting means is rotatable about a generally vertical few axis, about a generally horizontal second axis, about a third axis perpendicular to the second axis and is rotatable and translatable about and along the third axis, all with respect to the platform. 